Improving Services for Haematological Cancer. Application to London Cancer

Improving Services for Haematological Cancer Application to London Cancer Trust University College London Hospitals NHS Foundation Trust Clinical ...
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Improving Services for Haematological Cancer Application to London Cancer

Trust

University College London Hospitals NHS Foundation Trust

Clinical lead

Professor David Linch

Managerial lead

Mr Martin Lerner

Date completed

22nd July 2013

Applying to provide: BCSH Level 2b

BCSH Level 3

Proposed sites BCSH Level 2b

UCLH

BCSH Level 3

UCLH

Foreword th

Following the letter of the 12 June 2013 inviting UCLH to submit an application to London cancer to host Haematopoietic Stem Cell Transplantation (HSCT) and acute leukaemia services, we are delighted to provide our response as detailed in this application. The UCLH Board of Directors has endorsed the UCL Partners and London Cancer vision for improving outcomes, survival, functional recovery and patient experience of cancer patients across North and East London. We want the whole population to benefit from the national and international excellence in diagnosis, treatment, and care that we deliver here at UCLH. To achieve this, our Board of Directors has designated cancer as one of our key organisational priorities, and supported this with significant investment in the organisational capacity to deliver this vision for UCLH and for London Cancer. We have established a ground breaking partnership with Macmillan Cancer Support to deliver better patient experience alongside excellent treatments and outcomes offered at UCLH. Clinical haematology has always been a core part of our vision for cancer services. We provide dedicated clinical facilities for haematology patients in the University College Macmillan Cancer Centre which opened last year. We enjoy outstanding collaboration with the UCL Cancer Institute, which has arguably the best record in research into haematological cancer of any academic institution in Europe. By developing these two institutions adjacent to each other in Huntley Street, UCL and UCLH has shown their commitment to close integrated working between the outstanding clinical service and internationally recognised research in clinical haematology. There are many examples of direct benefits to patients resulting from this collaboration; one of the most significant of these is the development of new transplant protocols for the treatment of lymphoma which has been achieved by excellent collaboration between clinic, academic, and diagnostic groups at UCL and UCLH. These new protocols enable doctors to select the right transplant for the right patient, and provide significant survival benefits. We want this and many other examples of best practice to benefit the whole population of North and East London.

Our approach is based on the importance of outstanding clinical and academic leadership. We therefore acknowledge the key role that Professor David Linch will continue to play as the Head of Department of Haematology at the UCL Cancer Institute, as the Head of UCL/UCLH Cancer Research (UK) Centre, and as the Head of the cancer theme of our Biomedical Research Centre. This document provides initial thoughts on the implementation timetable. We will continue to work in partnership with London Cancer and NHS partner organisations at all stages of the implementation. We will work closely with the Royal Free Hospital (RFH) to ensure seamless transfer of HSCT, acute leukaemia, and allied services from RFH to UCLH and to ensure that RFH retain an effective Haematology Department, as outlined in this document. We will also cooperate fully in the Phase 2 exercise proposed by London Cancer to ensure the best possible working across the whole patient pathway for the benefit of the whole population of North and East London. The implementation plan will be modified in the light of these continuing discussions and also, where appropriate, the outcome of public consultation. We look forward to working with London Cancer on the implementation of these exciting proposals which will consolidate the Haematology services at UCLH as the leading centre in the UK for treatment and research into malignant haematological diseases.

Sir Robert Naylor Chief Executive

Improving Services for Haematological Cancer: UCLH Application to London Cancer

Introduction

Contents 1. 2. 3. 4. 5. 6.

Introduction ................................................................................................................................................................................ 1 Cancer Services at UCLH ........................................................................................................................................................... 2 Clinical Haematology Services at UCLH ................................................................................................................................. 10 Haematopoietic Stem Cell Transplantation (HSCT) and Acute Myeloid Leukaemia Services............................................. 24 Academics, Research and Clinical Trials ............................................................................................................................... 31 Delivering a New Pathway for Patients with Haematological Cancer ................................................................................... 42 Leadership.................................................................................................................................................................. 42 Patient Pathway ......................................................................................................................................................... 47 Joint Working with Other Hospitals.......................................................................................................................... 51 7. Maintaining Local Access and Enabling Patient Transport.................................................................................................. 55 Local Services ............................................................................................................................................................ 55 Transport .................................................................................................................................................................... 56 8. Improving Patients’ Outcomes and Experience .................................................................................................................... 60 Audit and Outcomes .................................................................................................................................................. 60 Patients’ Experience .................................................................................................................................................. 64 9. Providing the Capacity to Transform Services...................................................................................................................... 67 Organisational Capacity ............................................................................................................................................ 67 Impact of Change ....................................................................................................................................................... 71 Implementation Plan .................................................................................................................................................. 72 10. Conclusion: A High Quality Service for Patients and Carers ................................................................................................ 74 Appendix A: Outline of Proposed Level 2b (+AML) Unit ................................................................................................................. 75 Appendix B: Outline of Proposed Level 3 HSCT unit ...................................................................................................................... 84 Appendix C: Clinical Trials Recruitment in Haematology............................................................................................................... 93 Appendix D: Donor and Patient Surveys ......................................................................................................................................... 99 Appendix E: Letters of Support ...................................................................................................................................................... 107

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Introduction

1.

Introduction

1.1.

This document supports UCLH’s application to provide Haematological Cancer Services by outlining the Trust’s overall strategy and strengths, along with details of the current and proposed future service provision.

1.2.

It is acknowledged that combining existing specialist centres and establishing robust and efficient patient pathways for patients with haematological cancer is a complex task and will involve much collaboration between the organisations within North and East London. Our proposal focuses on the aspiration of providing a centre of excellence at UCLH.

1.3.

We have given careful consideration to the service specification produced and approved by the Haematological Pathway Board and have developed proposals

Domain

Reference

that will enable UCLH to achieve the aims and aspirations of London Cancer and to meet the specific requirements for Haematological Cancer Services. This document provides an overview of the strengths of UCLH’s clinical

Leadership

Section 6: page 42

Patient Pathway

Section 6: page 47

Joint Working

Section 6: page 51

Local Services

Section 7: page 55

Impact of Change

Section 9: page 71

Transport

Section 7: page 56

Audit & Outcomes

Section 8: page 60

Organisational Capacity

Section 9: page 67

services and research capability, with particular reference to cancer services, and demonstrates how we propose to achieve excellence against the criteria laid out in the service specification for Haematological Cancer. We have evidenced how we will deliver in the domains considered essential to a high quality patient pathway.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

2.

Cancer Services at UCLH

2.1.

The UCLH Board of Directors has endorsed the London Cancer vision: saving lives, improving patient experience, and optimising the quality of life of people living with cancer. By supporting the implementation of this vision, we will help the population of North and East London to benefit from cancer services which compete nationally and internationally on excellence in diagnosis, treatment, and care.

UCLH Vision and Values 2.2.

Implementation of the vision will be underpinned by the UCLH values which outline the behaviours and standards as to how we serve our patients.

2.3.

Our partnership with Macmillan Cancer Support further shapes our services for cancer patients and our innovation in care and support to people affected by cancer. Both UCLH and Macmillan Cancer Support are fully committed to sharing these innovations and improvements across the whole of London Cancer.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

Strategy for Cancer Services 2.4.

The UCLH Board of Directors has designated cancer as a key organisational priority and supported significant investment to create the capacity to deliver our vision for UCLH and London Cancer. Services for patients with haematological cancers have always been a key component of the UCLH commitment to the strategic development of cancer services. The leadership role which UCLH proposes to play in cancer services across London Cancer will build on existing strengths and expertise from many parts of UCLH working in collaboration with University College London (UCL), to improve cancer care across all parts of the patient pathway. Key components of our strategy for cancer services are articulated below.

Diagnostic Services 2.5.

The Department of Nuclear Medicine at UCL and UCLH was the first in UK to introduce Positron Emission Tomography (PET)/CT and PET/Magnetic Resonance Imaging (MRI) in clinical practice for cancer patients. Pioneering work between Haematology and Nuclear medicine in the use PET (CT) to determine the optimum treatment or transplant for patients with Lymphoma is described in Chapter 4.

Excellent Highly Specialised Treatment Hosted at UCLH 2.6.

UCLH already provides several nationally and internationally renowned specialist cancer services serving the population of London Cancer and beyond, including important advances in accurate diagnosis of prostate cancer, robotic surgery programme for prostate and bladder and other cancers, excellence in radiotherapy services including a high proportion of radiotherapy treatments which we deliver through Intensity-Modulated Radiation Therapy (IMRT). We have recently secured £125 million of central government funding to develop one of the UK’s first two Proton Beam Therapy (PBT) centres, due to open in 2018 to deliver the most accurate technical radiotherapy service to specific specialist patient groups who will benefit from this intervention.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

2.7.

The teenage and young adult cancer service at UCLH has developed from the first teenage cancer service which opened in 1990 at the Middlesex Hospital and is now the largest in the world, hosting 30 inpatient beds and a dedicated, state-of-the-art out-patient, day-care and ambulatory care facility. These patients benefit from access to world class cancer treatments, our ambulatory care model which allows people to stay in comfortable surroundings with their families, and a large, expert multidisciplinary team, dedicated to enabling every patient to achieve the psychosocial potential they have despite having experienced the challenges of cancer and cancer treatment.

2.8.

The Interventional Oncology Service at UCLH provides world-class image-guided cancer therapy for direct tumour treatment and cancer-related symptom control. Treatments include percutaneous tumour ablation (tumours are targeted in real time and destroyed using either heat (radiofrequency, microwave or laser ablation) or cold (cryotherapy); Vascular Oncology (tumours targeted through their blood supply to deliver chemotherapy or radiotherapy direct to the tumour) and pain control (using a variety of new techniques that involve the targeted delivery of analgesics to peripheral nerves, plexuses or more centrally).

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

Driving Research and Improvements in Treatment in Partnership with University College London 2.9.

Clinical research underpins all aspects of the high quality services at UCLH, the cornerstone being a highly developed clinical trials programme with a total of 1,050 patients entered into National Institute for Health Research (NIHR), academic, commercial and early phase clinical trials last year. A key feature of the commitment to cancer research at UCL and UCLH is the close proximity of translational and clinical laboratories (in the UCL Cancer Institute in Huntley Street) to the innovative treatment facility (the University College Hospital Macmillan Cancer Centre) directly opposite. From 2018, the new Proton Beam Therapy service will be housed in the basement of our new Phase 4 development in the same street as the Cancer Institute and Cancer Centre. This concentration of clinical and academic excellence in cancer will help to promote further innovations and improvements.

2.10. While researchers develop therapeutic advances in cancer, our Clinical Research Facility (CRF) in Phase 2 of University College Hospital provides a safe environment to trial these therapies and improve current and future treatments and outcomes. This early phase clinical trials facility is now the second largest of its kind in London (after the Royal Marsden Hospital). 2.11. UCLH is a key partner with the UCL Cancer Institute and Great Ormond St Hospital in the Cancer Research UK Centre. Research grant income to the Centre has increased from £19million in 2009 to over £41million this year, making it the second largest such Institute in the UK (the largest being the Institute of Cancer Research linked with the Royal Marsden Hospital). This Centre exemplifies the seamless integration of basic, translational and clinical cancer research with the outstanding treatment and care offered at UCLH.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

Innovative Models of Care and Patient Experience 2.12. Our new Cancer Centre opened in April 2012 and has won four awards for its design and contribution to improving cancer patient experience. We were delighted to have an inaugural visit to these fantastic facilities by Their Royal Highnesses the Prince of Wales and The Duchess of Cornwall. One of the most exciting features of the cancer centre is the innovative use of art work, which has been shown to have many positive therapeutic and medical outcomes for cancer patients. Coupled with the opening of a new patient hotel, which offers free accommodation to our patients and close relatives when they need it, we believe we are offering some of the most advanced cancer services in the UK. 2.13. Jeremy Hunt, Secretary of State for Health, recently acknowledged the quality of our cancer services and facilities on the NHS documentary Keeping Britain Alive: “Just been on inspirational visit to UCLH Macmillan Cancer Centre. Courage and optimism of cancer patients truly inspirational.”

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

2.14. UCLH offers a personal service to each cancer patient. Each patient will receive a personal treatment plan, a key worker to support them and their families throughout the pathway and full Clinical Nurse Specialist (CNS) support at all stages of their journey. In addition, the Macmillan Support and Information Service, based in the Cancer Centre, offers the benefit of a listening ear, a wide programme of activities to help cancer patients and to help them help themselves, and comprehensive patient information and advice. A variety of volunteer roles in the Cancer Centre further enhance the patient experience at all stages of their pathway.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

Our Commitment to Working with Patients 2.15. UCLH is committed to involving patients in helping us design and develop services. With the help of Macmillan Cancer Support, we have established a Cancer Patient Experience Board which is actively involved in all of our decisions about developing and designing services. Juliet Bouverie, Chair of this group and a member of our Cancer Clinical Steering Group has commented: The Patient Experience Board at UCLH provides a real opportunity for patients to help UCLH improve services to cancer patients. We have been impressed by the openness of the senior management team at UCLH to listen to views of patients and carers. I attend the Cancer Clinical Steering Group with one other patient member of the group and participate in all of the key strategic decisions, while members of the group are involved in a wide range of projects, co-design, and improvement work across the Trust.

2.16. We have also worked with London Cancer to ensure that patients are involved in designing wider pathways of care. Ben Wilson, a student from Watford, was diagnosed with Acute Lymphoblastic Leukaemia (ALL) when he was 17. He understands how it feels to be a teenager having regular treatment for cancer; “I was asked to join the Teenager and Young Adults Cancer Network Coordinating Group by Dr Rachael Hough, who was my consultant at University College Hospital in London and chair of the group, in 2012. I thought it sounded like a great idea and wanted to get involved. I’m able to discuss issues that really affect teenagers. I’ve raised things that haven’t been talked about before such as sexual health advice and information for teenagers with cancer. Other things like hospital food, exercise and getting back to school are really important to us as patients. Having the right information and support can help us continue to lead normal lives. At first, it was slightly intimidating to be in a room full of people who are leaders in their field. But they all take time to listen and my confidence has grown. I do believe our views will make a difference. It’s fascinating being behind the scenes. Knowing my contribution will help improve the situation for patients following behind me is really reassuring. “

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Cancer Services at UCLH

Our Commitment to Partnership Working 2.17. Our commitment to the vision of London Cancer is matched by our commitment to work in partnership with the other organisations across UCL partners to achieve this vision. We believe that joint consultant appointments between Trusts are an important driver of effective joint working, as these consultants can operate as full members of the specialist cancer services at UCLH and the cancer services at local units, ensuring that innovations in improvements in treatment are delivered locally wherever possible. We have pioneered joint appointments in medical oncology (with Barnet & Chase Farm Hospitals), in haematology (with North Middlesex University Hospital and Barnet & Chase Farm Hospitals, and Whittington Hospital) and in urology (with Barnet & Chase Farm Hospitals, the RFH, and the Barts Health group of hospitals) and we would introduce more joint consultant appointments in other specialties as the plans for Haematological Cancer Services are developed.

Our Capacity to Deliver 2.18. As an established Foundation Trust, with a successful financial track record, we have a reputation for delivering major projects and improvements within the NHS. We opened the award-winning Cancer Centre on time and on budget in April 2012. We successfully took on management of the Royal National Nose Throat and Ear Hospital (RNTNEH) from Royal Free London NHS Foundation Trust at the same time. We opened one of the first Hyper-Acute Stroke Units at University College Hospital in 2010 as part of the major reform of stroke services in London, which is estimated to have saved 400 lives per year. We completed the transfer of brain and spine cancer services from the RFH to UCLH in 2011 and 2012. We also cooperated fully with the transfer of specialist hepato-biliary cancer surgery to the RFH, when it was agreed that this provided the best model for improving these patient services. 2.19. The development of Cancer Services at UCLH is co-ordinated by our Cancer Clinical Steering Group, chaired by Dr Geoff Bellingan, Medical Director for Surgery and Cancer. Three Executive Directors, including Dr Gill Gaskin, Medical Director of the Specialist Board, attend this group together with the senior cancer clinical leadership of UCLH. The membership of the group includes two clinicians who chair National Clinical Reference Groups on specialist cancers for NHS England, and a further five clinicians whose expertise and leadership skills have been acknowledged by their appointment as Pathway Directors for London Cancer. All parts of UCLH are represented on this important group, together with representatives from our Patient Experience Board. This group ensures a co-ordinated approach to the delivery of improvements in cancer services across UCLH, including the proposals put forward in this document for Haematological Cancer Services. This overall commitment by UCLH to the provision of excellent specialist cancer services is matched by the specific strengths of UCLH which make us best placed to deliver the highly specialised cancer services for patients with haematological cancer; as described further in the following chapter.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Clinical Haematology Services at UCLH

3.

Clinical Haematology Services at UCLH

3.1.

This chapter describes the overall Clinical Haematology services provided at UCLH.

3.2.

UCLH provides a comprehensive range of clinical and laboratory services. The main focus areas for clinical activity in the department are: Haematopoietic Stem Cell Transplant Haematological oncology- lymphoma /myeloma /acute and chronic leukaemias / myelodysplastic disorders / myeloproliferative disorders Haemoglobinopathies Coagulation and thrombosis, including Thrombotic Thrombocytopenic Purpura (TTP) General haematology – other haematological disorders including immune cytopenia; referral service for the Trust and for GPs.

Haematology Facilities Inpatient Facilities 3.3.

The adult inpatient facility is housed over two floors of the UCH Tower. All 34 rooms are single rooms with ensuite facilities, many of which have the provision for a family member to stay overnight. Two of the rooms are fully equipped for radioisotope use and nine of the rooms have HEPA filtration.

3.4.

There are excellent age-appropriate facilities, both inpatient and outpatient, for teenagers and young adults. UCLH is the Principal Treatment Centre in North London for the TYA Cancer Network, forming the hub for care of cancer patients aged 13-24 years old in the sector. These patients include those with haematological malignancy and those undergoing HSCT. The adolescent cancer inpatient facility is part of the main adolescent floor. A th

designated Young Adult unit was opened in 2012 on the 13 floor for 20-24 year olds, adjacent to the adult Haematology area. This facility has 12 beds, and has been specifically designed to cater for the needs of this patient group.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

3.5.

Clinical Haematology Services at UCLH

The Critical Care Unit at UCH comprises general adult intensive care, high dependency, critical care outreach and a post- discharge follow up service. The Intensive Care Unit at UCH is a modern 35 bedded unit, providing 24 hour consultant led care. The unit has an optimal mixture of single rooms, four bedded bays and appropriate isolation facilities, and has an excellent track record in providing a high class service and leading on academic and clinical research in this area. Critical care is an invaluable resource for the haematology unit, and the working relationships are excellent. The unit has recently collaborated with the Department of Haematology to audit outcomes for haematology patients admitted to ICU, which led to a paper published in a peer-reviewed journal in 2013.

3.6.

Outreach is provided by the Patient Emergency Response Team (PERT), which is a nurse led team of experienced critical care nurses that assist in the care of ward patients who are acutely unwell or whose condition is deteriorating. The team consists of one nurse consultant, one critical care outreach nurse specialist and eight critical care outreach nurses. Ward staff call the PERT team according to clear trigger points, and the team provides a rapid assessment, advice and support service. PERT staff also liaise with critical care medical staff to facilitate safe and timely transfer between the critical care unit and the wards, and provide an outreach service for ongoing review of patients, as required, once they have been discharged from ITU.

3.7.

Infection control is a priority area within UCLH. Offering a multi-disciplinary approach, the team comprises of a Nurse Consultant and Director of Infection Prevention and Control, Infection Control nurses (Divisional Senior Nurse, senior IC nurse, eight IC nurses), Clinical Practice Facilitator, Wound Surveillance Team, Hospital Epidemiologist, Infection Control medical staff (medical microbiologists, virologists, infectious disease clinicians) and Biomedical Scientists (microbiology, virology).

3.8.

Microbiology ward rounds are conducted twice weekly on the haematology wards by a consultant microbiologist. There is a named virology consultant with responsibility for haematology, and a dedicated Infection Ward, with appropriate isolation facilities, on the eighth floor of the tower. Patients on the haematology wards who develop infections requiring isolation are moved to this ward. Haematology nurses maintain close links with the Infection Ward nursing staff, with haematology nurses staffing one shift per day on this ward and performing regular outreach.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Clinical Haematology Services at UCLH

The University College Hospital Macmillan Cancer Centre 3.9.

The Centre offers the most advanced service of its kind in the UK – redefining the way cancer patients are treated. The Centre offers ‘whole person’ care.

It has wellbeing, rehabilitation and cancer

survivorship at the heart of its philosophy. Ambulatory Care 3.10. UCLH has provided a pioneering Ambulatory Care service for cancer patients since 2004, treating almost 3000 patients. The unit administers and cares for individuals receiving what are traditionally inpatient treatments such as high dose chemotherapy and bone marrow transplantation, in an outpatient setting, often through the use of specialised pumps. Patients receive their healthcare in the ambulatory care area, either on the second floor (adults, from 25 years old), or on The Young Person floor (13-24 years old) of the Cancer Centre. The unit has a bay area with chemotherapy chairs and six additional single rooms. Current capacity is for up to 14 patients to undergo treatment concurrently, though alterations in the pathways are planned to enhance this capacity. 3.11. Patients are able to stay locally to the Hospital at one of two charitably funded residences. Patients have 24 hour access to unit nursing staff via mobile phone, and if they become unwell overnight, admission occurs to a bed saved on the Haematology Unit. The Cotton Rooms, a four star boutique hotel, funded by the UCLH Charity, offers 35 rooms with a range of accommodation types, from self-catering suites to twin and single rooms with a dining room and room service available and Paul’s House, a CLIC Sargent Home from Home, offers self-catering accommodation for young patients and their carers, for the duration of their treatment.

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Clinical Haematology Services at UCLH

3.12. Spending nights in these facilities rather than in hospital has proven extremely popular with patients. It has revolutionised the way care can be delivered, providing a pleasant, non-clinical environment in which to relax and minimising the length of time spent admitted to hospital. In a recent questionnaire, 100% of 136 patients stated that they would definitely come again for their next treatment. Patients’ highlighted the freedom and independence they gain, the comfortable environment of both the Cancer Centre unit and the hotel, and the improved diet and lack

of

institutionalisation when compared to an inpatient hospital setting.

3.13. The following are extracts taken from a service feedback form that patients and their companions are invited to complete “AC gives you a great sense of autonomy - in hospital you do not have that”. “When he came to visit me in the hotel, for him it didn’t seem like mummy was so ill”. “When you are in ambulatory care you don’t actually see yourself as being unwell, whereas being in hospital you think a lot more. In ambulatory care you can go shopping, out for dinner…it takes your mind off all sorts of things”.

Teenage and Young Adult 3.14. The third floor comprises the Teenage and Young Adult Unit, where the full range of outpatient activity including chemotherapy, clinics, ambulatory care and supportive care is performed. The floor has eight treatment pods, two isolation rooms, eight clinic rooms, a gym and a large recreational area.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Clinical Haematology Services at UCLH

Haematology Day care 3.15. The Haematology Day Care Department on the fourth floor of the Cancer Centre comprises two bays with treatment chairs, a four bedded bay, four single rooms for procedures and one room for pentamidine on the fourth floor. In addition blood products, infusions, venesections, planned procedures e.g. bone marrows and lumbar punctures, ad hoc medical review and triage for unwell patients are available on this floor. Outpatient Clinics and Other 3.16. Outpatient clinics are held primarily on the first and lower ground floors, with additional clinic rooms for haematology. 3.17. Other facilities in the building include phlebotomy, an FBC analyser (biochemistry analyser to follow); theatre facilities for minor procedures; CT scanning, plain imaging, ultrasonography, a PET-MRI scanner; additional specialist equipment, e.g. a dental suite. Chemotherapy 3.18. Outpatient adult chemotherapy is administered on the second floor of the Cancer Centre in a spacious environment with a choice of areas where patients can be treated. Single rooms are available for infectious or vulnerable patients. Staffing is with 12-13 chemotherapy-trained staff nurses per day. The chemotherapy preparation facility is also located on the second floor. All new patients are offered a consultation with a chemotherapy trained nurse prior to starting chemotherapy, to enable discussion of potential concerns. Pharmacy support to the chemotherapy unit is available throughout opening hours. Out of hours emergency chemotherapy can be produced 365 days a year. Intrathecal chemotherapy is administered on the second or fourth floors in specially designated rooms. Apheresis 3.19. There is a specifically designed apheresis facility on the fourth floor, with six beds in a large bay and two adjacent side rooms (for treatment of adolescent or infectious patients). There are eight apheresis machines staffed by four trained nurses, with up to two slots available for treatment per machine per working day. There is also a full 24 hour on call service provided by trained apheresis staff. This permits the running of a large and comprehensive programme:

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Clinical Haematology Services at UCLH

HSCT- harvesting autologous stem cells for recipients of autologous transplant, harvesting allogeneic stem cells and therapeutic T cells from related donors for UCLH and Great Ormond Street Hospital, and procuring these products from unrelated donors on behalf of the Anthony Nolan Trust, as one of the designated providers in the UK. Red cell - performing routine and emergency automated red cell exchange for patients with sickle cell disease. This has proven a very successful initiative, attracting referrals from elsewhere in London and beyond. Currently, 50 patients have been accepted onto the programme, but plans are in place to expand this to meet demand. Thrombotic Thrombocytopenic Purpura (TTP)- performing plasma exchange for patients with TTP. This is an immediately life-threatening condition and the scale of the programme at UCLH can support the emergency treatment of multiple patients presenting acutely (in hours and out of hours) with this condition. Exchanges can be performed twice daily, as required, and a machine is housed within the Tower, as treatments for these patients often have to be performed in ITU. Apheresis can also be performed on an emergency basis for patients presenting with other conditions, e.g. leucostasis from high count leukaemia, hyperviscosity syndromes from plasma cell disorders.

Macmillan Support and Information Service 3.20. The Macmillan Support and Information Service (MSIS) which opened in 2012 is an innovative venture in partnership with Macmillan Cancer Support. Situated on the ground floor of the Cancer Centre in a large dedicated area, it provides a comprehensive range of support services that is easily accessible for patients, their friends, family and staff. The MSIS also provides an outreach service for the inpatient wards. 3.21. The service is staffed by two joint Heads of Service, a Consultant Nurse, Clinical Nurse Specialist, Macmillan Cancer Information Specialist and team, Volunteering Manager with volunteer team, Welfare Rights Advisors, Senior Complementary Therapist and team, a Wig Coordinator and an Assistant General Manager from the Cancer Division.

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Clinical Haematology Services at UCLH

3.22. The MSIS, as part of its service delivers individual sessions, workshops, and group classes and covers issues including: diet, nutrition and exercise, welfare and benefits, headwear, wigs, complementary therapy (aromatherapy, massage, reflexology, Reiki), exercise classes, return to work/interview skills/CV preparation and counselling and emotional support throughout diagnosis, treatment and beyond.

Wolfson Cellular Therapy Unit 3.23. The Wolfson Cellular Therapy Unit (WCTU) was opened in 2006. This is a purpose-built facility, licensed (HTA registration No:11025) to carry out the processing, storage and distribution of cellular therapy products collected for the HSCT service and operating in accordance with the FACT-JACIE Standards. The WCTU is environmentally controlled for temperature and ventilation throughout and also for air quality in the controlled areas e.g. cleanroom. All processing steps which require exposure to the environment are performed in a biosafety cabinet, if possible, or Grade B environment.

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Clinical Haematology Services at UCLH

Linked Services Radiology 3.24. The Imaging Division at UCLH is formed of two Departments: Radiology and Nuclear Medicine, both of which are in an excellent position to support the Clinical Haematology Service. Both Departments support a wide range of sub-specialties, with close working relationships between the Imaging teams and the rest of the clinical teams in the Trust. Technical Excellence 3.25. The team of 28 Consultant Radiologists provides the full range of sub-specialty expertise to support the activities of the Trust, including internationally recognised expertise in sub-specialties including Head and Neck and GI Imaging. The Radiology Department offers a very responsive clinical service, providing a complete range of diagnostic and Interventional procedures to support patients. Much research and development is undertaken in the department, ensuring that the practices are at the cutting edge of Radiology practice. 3.26. Nuclear Medicine is the largest unit in the UK with a team of eight Consultants, and offers diagnostic and therapeutic studies across the spectrum of the specialty. The Department works closely with the HSCT team, performing PET scans both routinely and in the context of clinical trials, along with other research and development undertaken in the department. Currently the Department is the only centre in UK which uses state of the art biological tumour voluming with PET/CT for Radiotherapy planning studies. GFR, MUGA scans are also required for patients having chemotherapy during the course of their treatment. Availability of Innovative Equipment 3.27. The Radiology Department offers a wide range of state of the art equipment to support the patient pathway. This includes five MRI scanners (three x 1.5T, and two x 3T), which include ring-fenced research and development time to support new developments, and three CT scanners, two of which are being replaced in year, with state of the art equipment. UCLH has been invited to be the European reference centre for CT intervention with Toshiba. The department offers a one-stop service for a range of specialties, including Head and Neck and Urology. The Interventional service is designed to allow easy access for emergency patients requiring procedures. The department has particular expertise in biopsying extremely small abdominal lymph nodes facilitating prompt diagnosis, and receives tertiary referrals for this service.

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Clinical Haematology Services at UCLH

3.28. Nuclear Medicine has access to the entire range of conventional Nuclear Medicine imaging including two x PET/CT scanners, as well as the only PET/MR scanner currently in clinical use in the UK. 3.29. In summary, the Imaging Division at UCLH is ideally placed to provide a centre of excellence to the clinical haematology team, with staff and equipment to support it.

Pathology Laboratory Haematology 3.30. Laboratory Haematology includes both acute and specialist departments. The individual laboratories are all CPA-accredited and Blood Transfusion is MHRA compliant. The Haematology Acute departments comprise Autolab (Routine Haematology & Coagulation) and Blood Transfusion. AutoLab is a dual Haematology & Biochemistry laboratory which operates as a Public Private Partnership between Sonic Healthcare (The Doctors Laboratory) and UCLH NHS Foundation Trust Hospitals Laboratories. AutoLab undertakes over 10 million analyses per year of Biochemistry and Haematological samples. 3.31. The blood transfusion laboratory is one of the largest in the UK and one of only six hospitals in England that are designated as Blood Establishments. Blood transfusion provides patients with red cell, white cell, platelet and plasma haemostatic products. 3.32. The Haematology non-acute departments include Flow Cytometry, Specialist Haemostasis, Specialist Haematology, Haemoglobinopathy genetics & point of care testing. Histopathology 3.33. The Histopathology department at UCLH offers world class laboratory testing and excellent turn-around times. Currently, haematopathology at UCLH provides a service to both UCLH and the RFH. It is delivered by two dedicated, specialist and experienced histopathology consultants and supported by a third UCLH histopathologist and a Clinical Fellow who participate in the service rota. In addition there are two Honarary consultant haematopathologists from Barts Health and North Middlesex who attend the department one week each a month to support the growing workload. The haematopathology team is also supported by the UCLH cytopathologists and all of the histopathologists participate in the MDT meetings.

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Clinical Oncology 3.34. There is a named clinical oncologist with expertise in haematological malignancy who has responsibility for provision of services for Total Body Irradiation (TBI) for adult patients and a separate paediatric clinical oncologist with responsibility for adolescents. There are appropriate cover arrangements for both individuals. The consultations, consent, planning and treatment occur on site. The department has 5 Varian Linacs - 4 with onboard imaging facilities and all with MLCs and Portal Imaging. There are written policies for referral, planning and delivery of TBI.

Palliative Care 3.35. The UCLH Palliative Care team (part of the Camden, UCLH, HCA and Islington ELiPSe PC team) provides expert palliative and end of life care to any patient and/or their family at UCLH, who has a life threatening or life-limiting illness. The team also provides specialist advice for pain and other symptom control, e.g. nausea, mucositis. There are therefore strong working relations between palliative care and the haematology team, both for end of life care but also very frequently for assistance with symptom control in the non-palliative setting. 3.36. There is a daily presence on the wards, a weekly consultant ward round, and a weekly outpatients clinic within the Cancer Centre. The team works very closely with community based palliative care teams both locally and regionally, ensuring that patients are referred to receive support in the community in a timely manner, at any point along the disease trajectory. The service provides a visiting 24 hour on-call service for urgent assessment of new referrals and review / advice for existing patients with unstable or deteriorating symptoms.

Pharmacy 3.37. There is a dedicated team of pharmacists working within the area of haematology as part of the larger Cancer Services Pharmacy team. Clinical pharmacy services are provided to HSCT and acute leukaemia patients by three specialist haematology pharmacists, two rotational cancer services pharmacists and a medicines management technician. The team review all chemotherapy prescriptions from the ward/clinic or ambulatory care, ensuring that the regimen and doses are suitable for a specific patient as well as providing the patient will clear information regarding their supportive care medication. This provides a completely patient-focussed review. 3.38. Reconstitution of chemotherapy and other sterile preparation services (TPN, anti-virals etc) are provided by an onsite aseptic unit and UCLH is a high volume trust for intrathecal chemotherapy as defined by the DH (>600 doses per year).

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3.39. A specialist pharmacy advice and emergency chemotherapy service is provided out of hours, at weekends and on bank holidays by an on-call rota of cancer services pharmacists. As well as focussing on the clinical aspects to patient care, the pharmacy team helps with the review process of new drugs, clinical trials and analyses the financial aspects of the expensive drugs relating to the various treatments to support the directorate as a whole

Expert Staff 3.40. The haematology wards are staffed exclusively by registered nurses, all of whom are specifically haematology or HSCT trained, i.e. have a demonstrable career pathway within the specialty. In addition, 80% of the nursing establishment have a postgraduate qualification in haematology and/or oncology nursing. On both wards, the average nurse: patient ratio is 1:3, with a range of 1:1 to 1:5 depending on case mix and acuity. Patients receiving intensive treatment for haematology require the care of optimal numbers of skilled nursing staff and this is a particular area of strength at UCLH. 3.41. Specialist haematology nurses are integral to the successful delivery of treatment for haematological malignancy and are utilised in either diseasespecific roles, or technical support-specific roles. The disease-specific staff, (clinical nurse specialists / CNS’s) form an indispensable link between the patient and the various aspects of the healthcare system that the individual will encounter. The CNS oversees the patient through their treatment pathway, complementing the medical team in terms of education and support regarding the diagnosis, treatment plan and subsequent investigations and outcomes. 3.42. Technical support roles (Specialist Nurse Practitioners and Advanced Nurse Practitioners) provide expertise in the delivery of essential services such as central venous access, apheresis and chemotherapy administration. 3.43. The UCLH Haematology Department has an extremely strong specialist nursing network. The Divisional Senior Nurse for haematology oversees five distinct teams, each led by a senior nurse; HSCT CNS team: 8 members of staff (7.6 WTE)- 2 adult allogeneic HSCT, 1 adolescent HSCT, 2 autologous HSCT, 2 private patient HSCT, 1 donor coordinator White cell CNS team: 10 members of staff (9.5 WTE)- 3 lymphoma, 2 myeloma, 1 leukaemia, 1 TTP, 1 red cell, 1 support worker Inpatient adult chemotherapy team: 8 members of staff (6.8 WTE)- one senior sister, 4 haematology, 3 oncology. For Haematology inpatients, there are 10 - 20 patient episodes a day, ranging from low dependency short treatments to high

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dependency new patients starting complex regimens. The patients can be on the Haematology unit, or in other clinical areas within the Tower. Central Venous Access team: 7 members of staff (5.8 WTE)- 1 senior team leader, 5 ANP, 1 administrative support. This team is responsible for insertion of central venous devices. The preferred device for chemotherapy administration is an ultrasound and ECG-guided peripherally inserted central catheter (PICC line). The team is also trained and available to insert alternative devices, e.g. Vascaths and Hickman lines using the appropriate imaging. Importantly, in terms of patient experience, they provide a comprehensive pre-assessment and follow up service to advise on line-related issues, and regularly audit the outcomes of their line insertions. Apheresis Team: 7 members of staff (Band 6-7) managed by an 8a ANP Lead. This team provide therapeutic and stem cell collection services for a wide range of routine and emergency haematological malignancies. The team is the largest clinically based apheresis team in the UK and provides 24/7 cover 365 days of the year. The service also provides the same services to Great Ormond Street Hospital. Haematology Clinical Trials Team: The Haematology Trials Team has its own senior leadership provided by a job-share role, supporting 6.4WTE Nurses and Clinical Trial Practitioners who deal with the day-to-day aspects of study delivery, Data Managers and trial administrative support. Staff work with patients and studies in sub-type specific groups and provide comprehensive support for the high quality set-up and conduct of clinical trials according to GCP, national regulations and with specific local governance oversight and management. 3.44. The junior medical teams comprise two rotas. Daytime care is provided at ST1/2 level by seven staff (five haematology from the UCLH Core Medical Training rotation and two haematology clinical fellows), and out of hours cover by these doctors plus 13 additional oncology staff in a rota to provide two members of staff permanently resident. One of these doctors is assigned exclusively to the haematology patients, although there is collaborative working between the two depending on workload. Providing middle grade daytime cover, there are 10 ST3+ level registrars from the UCLH Specialist Registrar Training programme in Haematology and 3 clinical fellows. Out of hours these doctors plus eight UCL research registrars form a rota to provide non-resident care.

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Education 3.45. Ongoing opportunities for education both to maximise skills and performance, and to facilitate career development, are a priority area in haematology. Induction training and ongoing competency assessments are a mandatory aspect of all roles, in addition to which all types and grades of staff are encouraged to engage in ongoing education and professional development. 3.46. Nursing education is overseen by the Haematology Practice Development team comprising a Practice Development Lead CNS and three clinical practice facilitators. The Clinical Practice Facilitators work with nurses from induction through to senior clinical positions; helping promote personal and professional development and facilitating all statutory and mandatory education not covered by the Trust induction and update programmes. They also provide education and resources in the required areas of specific haematology training. 3.47. In addition to a mandatory Haematology Development Programme, a number of study days and educational opportunities are provided in house: Band 5 development study days Band 6 development study days New starter development programme - over 6 weeks AAR training - for management and to lead investigations Steli course - debriefing after simulation 3.48. The team also oversees the commissioning of post graduate specialist training and BSc and MSc pathways for staff – all of which are fully funded and supported with protected time. Staff are actively encouraged to access on-going education from one of the many partner organisations with which strong links have been built: King’s College London (BSc and MSc pathways and 'top-up' courses for first degrees) City University (Mentorship and physical assessment) Thames Valley University (management courses) Royal Marsden (MSc pathway, physical assessment, mostly Oncology focus)

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3.49. For junior medical staff, separate to the Trust induction and education programs, haematology specifically provides a bespoke unit induction, tailored to the needs of both the ST1/2 level staff, and to the needs of the ST3+ level staff. Further to this, training specific to the staff group is provided through ST1/2- weekly teaching sessions on topics in Haematology by ST3+ registrars and Haematology consultants conduct teaching sessions on the formal UCLH CMT teaching programme. Consultant training is also provided via educational and clinical supervision while attached to the haematology unit, e.g. ward rounds, clinic visits, workplace-based assessments. 3.50. For ST3+ staff, there is weekly consultant morphology teaching, educational and clinical supervision by consultants as for ST1/2 and regular Londonwide trainee education days. Junior medical staff are also encouraged to utilise in-house education opportunities, e.g. the Executive shadowing programme, and to attend study days, management courses, research meeting or seminars wherever possible. There is also a strong tradition of junior medical staff contributing to research and audit in the unit, and being involved in writing up manuscripts for publication and presenting orally or via poster at national and international meetings. 3.51. Finally, the majority of ST3+ trainees who enter the UCLH specialist registrar rotation opt for out of programme experience in order to gain a higher degree. Though not mandatory, this is strongly encouraged at UCLH and opportunities for research in all areas of haematology are available via the Department of Haematology at UCL. The department also attracts Academic Clinical Fellowships in Haematology and opportunities are available to enter academic training via this route.

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HSCT and Acute Myeloid Leukaemia Services

4.

Haematopoietic Stem Cell Transplantation (HSCT) and Acute Myeloid Leukaemia Services

4.1.

This chapter describes the specific services for Haematopoietic Stem Cell Transplantation and Acute Myeloid Leukaemia at UCLH.

Haematopoietic Stem Cell Transplantation (HSCT) 4.2.

The transplant programme at UCLH was started in 1979, by Professor AH Goldstone and Professor David Linch. The first procedures undertaken were autologous transplants followed by allogeneic transplantation and subsequently a comprehensive adult and adolescent programme developed, with one of the largest tertiary referral practices in the UK for all types of autologous and allogeneic transplants ( HLA-matched related, HLA-matched and mismatched unrelated, umbilical cord blood). The unit performs approximately 70 allogeneic and 100 autologous transplants per year and the full range of conditioning regimens is available, with a clinical oncology service providing radiotherapy on site for protocols containing total body irradiation.

4.3.

UCLH also procures peripheral blood stem cell, bone marrow harvest and donor lymphocyte products from healthy unrelated donors on behalf of the Anthony Nolan Trust and similar products for related adolescent and adult donors on behalf of Great Ormond Street Hospital. A full range of cell processing and storage of harvested products is also performed on site, at the Wolfson Cellular Therapy Unit.

4.4.

The unit has a strong track record in delivering translational research in transplantation, publishing over 60 papers arising from clinical studies in peerreviewed journals in the last 10 years and leading on the development and delivery of various novel therapies.

4.5.

There are dedicated inpatient and outpatient facilities for each patient group, in the Tower and University College Hospital Macmillan Cancer Centre, as outlined previously. The facility for harvesting by apheresis is located on the fourth floor of the Cancer Centre, and bone marrow harvests are performed in the main theatre suite of the University College Hospital tower. The processing facility is the Wolfson Cellular Therapy Unit.

4.6.

There are three consultants specialising in adult HSCT, with additional input from four more consultants with disease-specific interests. There are also two consultants specialising in adolescent HSCT. There are two transplant specialist registrars and one CMT. The CNS team has eight members (two autologous HSCT, two allogeneic HSCT, one adolescent, two private patients, one donor coordinator). There is in addition a full time Quality Manager.

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Activity 4.7.

Annual activity (from the Annual Report 2011/12) Autologous transplants n=96, 1 year overall survival 95% Allogeneic transplants n=66, 1 year overall survival 80% Collection: bone marrow harvest = 30; apheresis, see below

HPC,A Autologous Adolescents, 14, 1%

TC, Apheresis Allo, 24, 2%

HPC,A Autologous Adults, 194, 14%

Leucopdepletion, 24, 2% Red Blood Cell Exchange, 345, 25% Other, 974, 62%

HPC,A Allogeneic (for 3rd Party), 144, 10%

Therapeutic Plasma Exchange, 605, 38%

HPC,A Allogeneic Adolescents, 8, 1% HPC,A Allogeneic Adults, 31, 2%

4.8.

Processing: 542 cellular products from 431 donors were processed by the WTCU; 951 units were cryopreserved and 565 cryopreserved units were distributed for infusion.

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Key Service Developments 4.9.

The following identifies the key developments in the Haematological Cancer Service at UCLH: A dedicated Adolescent Cancer Unit (13-19 years) was opened in 2005, as UCLH became the designated provider for adolescent HSCT and haematological cancer services in North Thames (Lead: Dr Rachael Hough, consultant in Adolescent Haematology and HSCT) . The Wolfson Cellular Therapy Unit was opened in 2006. UCLH underwent a successful inspection by the Joint Accreditation Committee- ISCT (Europe) and EBMT (JACIE) in November 2009 and is fully accredited for the provision of clinical, collection and processing services for adult and paediatric transplantation. UCLH underwent a successful inspection by the Human Tissue Authority in December 2009 and is licensed for the procurement, testing, processing, storage, distribution and import/export of tissue and cells for human application. A dedicated Young Adult Unit (20-24 years) was opened at University College Hospital in 2012, for provision of HSCT and haematological cancer services for this age group. UCLH is the designated provider for North Thames (Lead: Dr Rachael Hough)

Key Advances in Clinical and Translational Research 4.10. Professor Goldstone and Professor Linch led the development of BEAM conditioning for autologous transplantation in lymphoma, a regimen which remains the standard of care. The first randomised study of this regimen in Hodgkin lymphoma was published in the Lancet in 1993. 4.11. Professor Mackinnon pioneered the use of a novel reduced intensity conditioning regimen (FMC) in 1996. The programme has proven highly successful, and has led to a series of publications on this approach as a platform for posttransplant immunotherapy in the treatment of otherwise incurable haematological malignancies. In many cases this has been in collaboration with other centres who subsequently adopted the regimen: Outcomes for large disease-specific cohorts of patients with Hodgkin lymphoma (Peggs et al, Lancet, 2005), diffuse large B cell lymphoma (Thomson et al, JCO 2009), follicular lymphoma (Thomson et al, JCO 2010) and CLL (Richardson et el, BJH 2013) have been published, demonstrating the potential for cure in these diseases.

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In addition, the role of adoptive immunotherapy using donor lymphocytes after transplant to modulate mixed chimerism and prevent or treat relapse has been extensively investigated (Peggs et al, Blood 2004; Bloor et al, BBMT 2008; Peggs et al, JCO 2011; Mohammedhbai et al, BJH 2012). A multicentre study of CD8 depleted donor lymphocytes is currently recruiting, led by Dr Chakraverty at UCL/RFH. The PET scan images to the right show a patient with relapsed lymphoma, and then a further scan after treatment with donor lymphocytes, showing complete remission. The unit has also investigated aspects of the use of alemtuzumab in this conditioning strategy, with an initial pharmacokinetics study (Morris et al, Blood 2003) which then informed a de-escalation study (Chakraverty et al, Blood 2010), setting the current standard for dosing in sibling allogeneic transplant. 18

Finally, the use of functional imaging ( FDG-PET CT scans) to detect early recurrence and therefore direct intervention with immunotherapy has also been studied, first retrospectively (Hart et al, BJH, 2005) and then in a prospective trial (Lambert et al, Blood 2010), permitting an optimised pre- and post- transplant surveillance strategy. 4.12. The unit has also been at the forefront of translational studies using adoptive cellular immunotherapies (donor-derived virus-specific T lymphocytes) to treat CMV reactivation in patients following transplantation. The programme was commenced by Professor Mackinnon and the first work was published in the Lancet in 2003 (Peggs et al), leading to a second prospective trial (Peggs et al, CID 2009), and subsequently the development of two multi-centre randomised NCRI-badged studies, one in sibling transplants and one in unrelated donors, both led by Dr K Peggs. One has recently finished recruitment, and the other is close to completing recruitment. These are the first randomised confirmatory studies of CMV-specific cellular therapy to be performed anywhere in the world. Importantly, these studies are being performed in a close collaborative working partnership with a British Biotech partner (Cell Medica), ensuring a clear pathway to market.

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4.13. UCLH is also pioneering a novel strategy for managing relapsed or refractory Hodgkins lymphoma. This builds on the initial experience of reduced intensity conditioning in HL, taking into account the relapse rate seen, the utility of

18

FDG PET-CT surveillance and of donor lymphocyte use. This

strategy involves an augmented conditioning regimen for those receiving an allogeneic transplant, and the choice of consolidation is directed by disease response pre-transplant. This results in improved patient selection and therefore ensures the right transplant is performed in the right patient at the right time. Pilot data is extremely encouraging, with 91% overall survival at three years for those undergoing transplant procedures, and a national NCRI/BSBMT-badged multicentre phase II study is underway (PAIReD), led by Dr K Peggs. 4.14. Building on our extensive expertise and national leadership in clinical translation of cellular therapies, we are also about to initiate a trial of allodepleted T cell add-back in patients having transplants for acute leukaemia (ICAT). This trial marks a closer research collaboration with colleagues at Great Ormond Street Hospital. The trial is led by Professor P Amrolia (GOSH) and Dr K Peggs, with funding from the MRC DPFS/DCS. It also marks an expansion in the capabilities of the UCLH stem cell facility in terms of expertise in the field of Advanced Therapeutic Medicinal Products (ATMPs), which will be invaluable as such therapies become part of mainstream transplant practice in coming years. 4.15. We have recently been awarded a further grant in collaboration with industry by the Technology Strategy Board in order to expand the reach of our cellular immunotherapy programme. This will fund a new cellular therapy study (PRECISE) in patients with Graft-versus-Host disease, and marks our first interaction with the Cellular Therapy CATAPULT in a multinational trial (UK/Germany) to be led by UCLH (Dr K Peggs) 4.16. Finally, gene therapy is a major focus of interest at UCL. Dr E Morris has successfully utilised transfer of TCR genes in order to redirect the specificity of T lymphocytes. Two early phase clinical studies are open and recruiting. In one, the T cells are engineered to provide anti-CMV effects to control infection following allogenic HSCT and in the other, the T cells are equipped with WT1-specific receptors designed to provide anti-leukemia effects. This type of new generation cellular immunotherapy study demonstrates that UCL is at the international forefront of cell and gene therapy in the context of stem cell transplantation. The translational research activity, underpinned by large UCL research groups, is completely integrated with the clinical service and builds on the unit's established expertise in cellular therapies.

Acute Myeloid Leukaemia 4.17. UCLH provides a full range of AML services for patients aged 13 years upwards, from comprehensive diagnostics, full age-appropriate inpatient and ambulatory care facilities for all forms of induction and consolidation chemotherapy, and outpatient follow up in specialists clinics. In the last year, 45 adult patients have been diagnosed with AML at UCLH and 34 have received intensive chemotherapy.

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4.18. The lead for acute leukaemia services at UCLH is Professor Asim Khwaja, and a joint AML/MDS clinic is run with a further consultant with a specialist interest in MDS, Dr Beth Payne. Nine additional haematology consultants participate in the attending rota. There is a dedicated acute leukaemia CNS, with cover from within the white cell CNS team. The inpatient junior medical team includes two inpatient White Cell Specialist Registrars with crosscover from a White Cell Fellow, and two core medical trainees. Out of hours cover is via the haematology CMT, haematology registrar and consultant. 4.19. The unit has a strong record in participation in clinical trials in AML, both early phase I/II and large phase III: an early phase study of PARP inhibition in relapsed/refractory AML has recently completed. an early phase study of Hedgehog inhibition is shortly to open. discussions are ongoing regarding phase two studies using an IL3 receptor antibody and lysine-specific demethylase 1 (LSD1) inhibitor. the second of the two early phase gene therapy studies led by Dr E Morris described above, targeting WT1-expressing acute leukaemia cells, is open and primarily aimed at recruiting patients with high risk acute myeloid leukaemia, providing a novel therapy for those in whom conventional therapies have failed or would be predicted to be of no value. AML17- the main national study in younger patients. As of May 2013, 2371 patients had been recruited from 133 centres and UCHL was the fifth highest contributing centre. LI1- the national study for older patient not fit for intensive chemotherapy AML18 pilot- this pilot study for older patients fit for intensive chemotherapy is in follow up, and the definitive national study will open shortly.

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4.20. In addition, Professor Linch and Professor Gale at UCL have conducted a highly successful and productive programme of laboratory research in relation to the molecular and cytogenetic abnormalities found in acute myeloid leukaemias. As part of this programme, their laboratory has undertaken analysis of thousands of samples collected during successive national studies. The availability of high quality samples on large numbers of patients along with clinical outcome data has permitted important advances in prognostication and therefore treatment of this disease over the years, and over 20 publications in major journals have resulted from this work. 4.21. In particular, this data has strongly influenced the current treatment of AML by elucidating factors that are used around the world (US, European and British guidelines) as key criteria for advising treatment with an allogeneic HSCT. Both the most recent U.S. National Comprehensive Cancer Network Clinical Practice Guideline for AML (2012) and the European LeukemiaNet guideline on diagnosis and management of AML (2010) heavily reference and follow the conclusions from these research publications, and the British counterpart (BCSH) has adopted the European LeukemiaNet guidance. 4.22. Key areas have included investigating the prognostic significance of IDH1 status in 1333 patients with AML and of IDH2 status in 1473 patients (Green et al, Blood 2010; Green et al, Blood 2011); of CEBPA mutations in 1427 patients (Green et al, JCO 2010) and of FLT3 ITD and TKD mutations in >1000 patients (Gale et al, Blood 2008; Mead et al, Blood 2007; Gale et al, Blood 2005; Kottaridis et al, Blood 2001). 4.23. The UCL laboratory remains highly active in this area, performing tissue archiving and molecular analysis of samples collected during the current national AML studies.

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5.

Academics, Research and Clinical Trials

Academics, Research and Clinical Trials

Vision 5.1.

Our vision is to maintain and augment our position over the next decade as a world leading haematological malignancy research centre. The emphasis is on translational research, but this is to be conducted in an environment where more basic research is on-going and can be rapidly applied to clinical situations.

Background 5.2.

Haematology research is conducted in the Paul O’Gorman building (Cancer Institute) which was opened in 2007 and is directly opposite the UCLH MacMillan Cancer Centre opened in 2012. Research into haematological malignancies accounts for about a third of all activity in the Cancer Institute.

Professor Boshoff (Medical Oncology) is the Director of the Cancer

Institute and works on viral oncogenesis including lymphomagenesis. There are very close interactions between the haematology researchers, non-haematological cancer research scientists and more basic cell biologists. The Cancer Institute is the focus for the UCL CRUK Cancer Research Centre which brings together cancer research in the wider UCL and UCLH community including members of the Faculty of Biological Sciences, the Institute of Child Health and the RFH. Clinical and research staff in Haematology who are based at the Royal Free are also an integral part of the Cancer Institute, and there is a strong tradition of close collaboration between staff on both sites to form a unified academic approach.

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5.3.

Academics, Research and Clinical Trials

Professor D. Linch (Haematology) has been the inaugural Chairman of the CRUK Cancer Centre and after four years rotates from this post in September 2013. The success of the CRUK Cancer Centre at UCL is reflected in the fact that it is one of five Cancer Centres in the UK invited to apply for “CRUK Major Research Centre” status. UCLH also makes a major commitment to cancer research and is a major partner in the CRUK Cancer Centre. UCLH/UCL are recipients of an NIHR Biomedical Research Centre (BRC) award and cancer research is one of the two main programmes within the BRC. Professor David Linch is the Cancer Programme Director. Clinical trials have a high priority at UCLH and this is facilitated by an early phase Clinical Research Facility and the CRUK and UCL Cancer Trials Centre. The Trials Centre contains the Lymphoma Trials Office, which manages most of the national Lymphoma trials. Overall, UCL is regularly assessed as being within the top twenty Universities for biomedical research world-wide.

Specific Research 5.4.

The research cited below is not exhaustive and is focussed on those areas most relevant to transplantation, acute leukaemia and novel therapies.

Acute Leukaemia Professor Tariq Enver and Dr Rajeev Gupta are world leaders in research into the biology of leukaemic stem cells in both acute myeloid leukaemia (AML) and acute lymphoblastic leukaemia (ALL). Their work is directly relevant to the understanding of why patients relapse after attaining a remission. Professor Enver and Dr Adele Fielding from the RFH are also collaborating on studies in leukemic stem cells in adult ALL. Dr Elspeth Payne is modelling myelodysplastic disorders in Zebrafish with a view to developing novel therapies for MDS/AML. Professors Rosemary Gale and David Linch are studying the molecular pathogenesis of adult AML and adult ALL. Appreciation of recurrent mutations facilitates prognostic stratification and the selection of patients for transplantation in first complete remission (as described in Chapter 4) Professors Rosemary Gale, Asim Khwaja and David Linch study the biological consequences of recurrent mutations with a view to developing novel therapies. Professor Khwaja, who first identified the pivotal role of the PI3K-AKT anti-apoptotic pathway, is an expert in signal transduction and kinase inhibitors.

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Lymphoma and Myeloma Dr Teresa Marafiotis’s research focuses on improved diagnostics for non-Hodgkin’s lymphomas. Dr Martin Pule and Professor David Linch are carrying out translational studies in relation to the national lymphoma trials (e.g. importance of immune effector molecule polymorphisms in antibody therapy). There are also on-going mutational screens in collaboration with Dr. J. Fitzgibbon at Barts Health. Professor Kwee Yong studies the relationship between expression of different D type cyclins in myeloma the response to cytokines and susceptibility to radiation damage. Professor Asim Khwaja and Professor Kwee Yong are studying the pro-survival signalling events in myeloma with a view to determining which combinations of inhibitors should be taken into clinical trials.

Immunotherapy and Bone Marrow Transplantation Dr Sergio Quezada and Dr Karl Peggs have a laboratory programme studying the manipulation of immune regulatory pathways and the role of cytotoxic CD4+ cells in haematological and non-haematological malignancies. This is relevant to both the transplant and non-transplant situation, and has resulted the establishment of a number of collaborative research agreements with other key groups within Oncology working within UCLP. Dr Martin Pule and Professor Nathwani are developing Chimeric Antigen Receptor (CAR) T cells for the treatment of relapsed/resistant/poor prognosis ALL, non-Hodgkin’s lymphoma including CNS lymphomas and CLL. Some of the initial studies will be in the post allograft situation. A component of these programmes is the development of universal CAR T cells applicable to all patients and obviating the need for expensive patient-specific T cells. Dr Pule and Dr Peggs have recently received a €6M grant from the EU for this work. Dr Ron Chakraverty runs a preclinical research programme at the Royal Free campus investigating the biology of graft-versusleukemia and graft-versus-host disease in HSCT

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Clinical Trials Programme 5.5.

The Clinical Trials programme at UCLH is facilitated by the existence of an early phase Cancer Clinical Research Facility in Phase II of the new UCLH as well as close links with the Sarah Cannon Trials Unit (e.g. Dr K Ardeshna is PI of a Sarah Cannon Phase II study of PI3k inhibitor in NHL). There is also an excellent team of trials nurses and data managers within the Haematology Division at UCLH for the conduct of Phase II and Phase III trials in the haematology outpatients and ward areas. The design and management of trials is aided by the co-location of the CRUK and UCL Cancer Trials Centre. The Lymphoma Trials Office is a component of this centre and has now extended its activities to trials in leukaemia (e.g. UKALL 14), myeloma and bone marrow transplantation. UCLH is a major participant in national Phase III trials and this will continue to be given top priority when the PI is from the UCL/UCLP community (e.g. adult ALL trials where Dr. Adele Fielding from the RFH is the CI). In other situations we anticipate greater focus on Phase I and II trials especially where they are dependent on local laboratory research. This brings us fully into line with the experimental medicine remit of the UCL/ULCH BRC. To be able to complete on an international stage in such trials, close collaboration between all centres in UCLP is essential and productive discussions between the clinicians at UCLH, RFH and Bart’s Health are in progress.

5.6.

Specific trials led by UCL/UCLH are as follows:

Transplantation (as previously outlined in Chapter 4) Dr Karl Peggs is the CI of two NCRI-badged trials addressing the value of CMV-specific T Cells following both sibling and unrelated donor transplants. This is a collaboration with industry (CellMedica). Dr Karl Peggs is the CI for a national NCRI-badged multi-centre Phase II study on reduced intensity transplantation for Hodgkin lymphoma. Dr Emma Morris is CI for a Phase I study of adoptive immunotherapy with CMV TCR-transduced donor-derived T cells for recipients of allogeneic HSCT. Dr Rachael Hough (Adolescent Haematology) is the CI for two national NCRI-badged multi-centre studies of umbilical cord blood transplantation. Priority will be given to trials attempting to augment the graft versus tumour effect without increasing graft versus host disease that are anticipated from the preclinical research of Dr Ronjon Chakraverty at the RFH .This a perfect ‘natural fit’ given our worldleading expertise in cellular therapies and our industry contacts.

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Academics, Research and Clinical Trials

Non Transplant Trials Professor Kwee Yong leads a series of single and multicentre trials for the treatment of myeloma both commercial and noncommercial. These studies have a major bearing on which myeloma patients should be considered for autologous bone marrow transplantation, which is currently standard therapy. UCLH has been selected as a Phase I centre for the Myeloma UK Clinical Trials Network and currently two Phase I trials are open. UCLH is also a major contributor to the national Phase III myeloma trials. A series of Phase II trials in NHL are in progress, in collaboration with industry. These are run by Dr Kirit Ardeshna and Dr Rakesh Popat. UCLH was the highest UK recruiter in the two mantle cell lymphoma trials and was the third highest recruiter internationally in one of these trials (MCL 2001 SPARK trial). UCLH is a major contributor to the national lymphoma trials. Professor Linch is the Director of the Lymphoma Trials Office and was a previous Chairman of the NIHR Lymphoma Clinical Studies Group. Lymphoma is a disease we are targeting for our gene therapy/CAR-T cell therapy programme. UCLH is a major contributor to the national adult acute leukaemia trials and this is an area where we anticipate a series of local (UCLH/UCLP) early phase trials. Priority will be given to gene-engineered T cell therapy trials evolving from the work of Dr. Emma Morris and Professor Hans Stauss at the RFH. Dr Morris is CI for a multi-centre Phase I/II study of WT1 TCR Gene Therapy for Leukaemia.

Research Training 5.7.

The Cancer Institute at UCL has given major priority to the training of PhD students and Clinical Fellows. A post gradual tutor oversees their progress in addition to their primary and secondary supervisors. 175 training and skills courses are available to students and Fellows. There are now over 100 students and Fellows enrolled for further research degrees in the Cancer Institute.

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Academics, Research and Clinical Trials

Publications in Last Five Years 5.8.

This is a selected list of papers published in journals with an Impact Factor > 10, during this period.

Author

Title

Publication

Bowen D, Groves MJ, Burnett AK, Patel Y, Allen C, Green C, Gale RE, Hills R, Linch DC.

TP53 gene mutation is frequent in patients with acute myeloid leukemia and complex karyotype, and is associated with very poor prognosis.

Leukemia 231: 203-6.

Brewin J, Mancao C, Straathof K, Karlsson H, Samarasinghe S, Amrolia PJ, Pule M.

Generation of EBV-specific cytotoxic T cells that are resistant to calcineurin inhibitors for the treatment of post transplantation lymphoproliferative disease.

Blood. 2009 Nov 26;114 (23):4792-803.

Fielding AK, Rowe JM, Richards SM, Buck G, Moorman AV, Durrant IJ, Marks DI, Kyriakou C, Canals C, Finke J, Kobbe G, Harousseau JL, Kolb HJ, Novitzky N, Goldstone AH, Sureda A, Schmitz N.

Allogeneic stem cell transplantation is able to induce long-term remissions in angioimmunoblastic T-cell lymphoma: a retrospective study from the lymphoma working party of the European group for blood and marrow transplantation.

J Clin Oncol. 2009 Aug 20;27 (24):39518.

Hoskin PJ, Robinson M, Slevin N, Morgan D, Harrington K, Gaffney C.

Effect of epoetin alfa on survival and cancer treatment-related anemia and fatigue in patients receiving radical radiotherapy with curative intent for head and neck cancer.

J Clin Oncol. 2009 Dec 1;27(34):5751-6.

Lambert JR, Everington T, Linch DC, Gale RE.

In essential thrombocythaemia, multiple JAK2-V617F clones are present in most mutant-positive patients: a new disease paradigm.

Blood. 2009 Oct 1;114(14):3018-23.

Mansour MR, Sulis ML, Duke V, Foroni L, Jenkinson S, Koo K, Allen CG, Gale RE, Buck G, Richards S, Paietta E, Rowe JM, Tallman MS, Goldstone AH, Ferrando AA, Linch DC.

Prognostic implications of NOTCH1 and FBXW7 mutations in adults with T-cell acute lymphoblastic leukemia treated on the MRC UKALLXII/ECOG E2993 protocol.

J Clin Oncol. 2009 Sep 10;27(26):4352-6.

Marks DI, Paietta EM, Moorman AV, Richards SM, Buck G, DeWald G, Ferrando A, Fielding AK, Goldstone AH, Ketterling RP, Litzow MR, Luger SM, McMillan AK, Mansour MR, Rowe JM, Tallman MS, Lazarus HM.

T-cell acute lymphoblastic leukaemia in adults: clinical features, immunophenotype, cytogenetics, and outcome from the large randomized prospective trial (UKALL XII/ECOG 2993).

Blood. 2009 Dec 10;114 (25):5136-45.

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Academics, Research and Clinical Trials

Author

Title

Publication

McMillan AK, Litzow MR, Lazarus HM, Foroni L, Dewald G, Franklin IM, Luger SM, Paietta E, Wiernik PH, Tallman MS, Goldstone AH.

Prospective outcome data on 267 unselected adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia confirms superiority of allogeneic transplantation over chemotherapy in the pre-imatinib era: results from the International ALL Trial MRC UKALLXII/ECOG2993.

Blood. 2009 May 7;113 (19):4489-96.

Peggs KS, Quezada SA, Chambers CA, Korman AJ, Allison JP.

Blockade of CTLA-4 on both effector and regulatory T cell compartments contributes to the antitumor activity of anti-CTLA-4 antibodies.

J Exp Med. 2009 Aug 3;206 (8):1717-25.

Thomson KJ, Morris EC, Bloor A, Cook G, Milligan D, Parker A, Clark F, Yung L, Linch DC, Chakraverty R, Peggs KS, Mackinnon S.

Favorable long-term survival after reduced-intensity allogeneic transplantation for multiple-relapse aggressive non-Hodgkin's lymphoma.

J Clin Oncol. 2009 Jan 20; 27(3):426-32.

Tosello V, Mansour MR, Barnes K, Paganin M, Sulis ML, Jenkinson S, Allen CG, Gale RE, Linch DC, Palomero T, Real P, Murty V, Yao X, Richards SM, Goldstone A, Rowe J, Basso G, Wiernik PH, Paietta E, Pieters R, Horstmann M, Meijerink JP, Ferrando AA.

WT1 mutations in T-ALL.

Blood. 2009 Jul 30;114 (5):1038-45.

Burnett AK, Hills RK, Milligan DW, Goldstone AH, Prentice AG, McMullin MF, Duncombe A, Gibson B, Wheatley K.

Attempts to optimize induction and consolidation treatment in acute myeloid leukemia: results of the MRC AML12 trial.

J Clin Oncol. 2010 Feb 1;28(4):586-95.

Burnett AK, Hills RK, Green C, Jenkinson S, Koo K, Patel Y, Guy C, Gilkes A, Milligan DW, Goldstone AH, Prentice AG, Wheatley K, Linch DC, Gale RE.

The impact on outcome of the addition of all-trans retinoic acid to intensive chemotherapy in younger patients with nonacute promyelocytic acute myeloid leukemia: overall results and results in genotypic subgroups defined by mutations in NPM1, FLT3, and CEBPA.

Blood. 2010 4;115(5):948-56.

Chakraverty R, Orti G, Roughton M, Shen J, Fielding A, Kottaridis P, Milligan D, Collin M, Crawley C, Johnson P, Clark A, Parker A, Bloor A, Pettengell R, Snowden J, Pettitt A, Clark R, Hale G, Peggs K, Thomson K, Morris E, Mackinnon S.

Impact of in vivo alemtuzumab dose before reduced intensity conditioning and HLA-identical sibling stem cell transplantation: pharmacokinetics, GVHD, and immune reconstitution.

Blood. 2010 Oct 21;116(16):3080-8.

Foukas LC, Berenjenoa Vanhaesebroeck B.

Activity of any class IA PI 3-kinase isoform can sustain cell proliferation and survival. (*equal contribution)

Proc Natl Acad Sci U S A. 2010 22;107(25):11381-6.

IM,

Gray

A,

Khwaja

A,

37

Feb

Improving Services for Haematological Cancer: UCLH Application to London Cancer

Academics, Research and Clinical Trials

Author

Title

Publication

Green CL, Evans CM, Hills RK, Burnett AK, Linch DC, Gale RE.

The prognostic significance of IDH1 mutations in younger adult patients with acute myeloid leukemia is dependent on FLT3/ITD status.

Blood. 2010 Oct 14;116(15):2779-82.

Green CL, Koo KK, Hills RK, Burnett AK, Linch DC, Gale RE.

Prognostic significance of CEBPA mutations in a large cohort of younger adult patients with acute myeloid leukemia: impact of double CEBPA mutations and the interaction with FLT3 and NPM1 mutations.

J Clin Oncol. 2010 Jun 1;28(16):2739-47.

Grimwade D, Hills RK, Moorman AV, Walker H, Chatters S, Goldstone AH, Wheatley K, Harrison CJ, Burnett AK; National Cancer Research Institute Adult Leukaemia Working Group.

Refinement of cytogenetic classification in acute myeloid leukemia: determination of prognostic significance of rare recurring chromosomal abnormalities among 5876 younger adult patients treated in the United Kingdom. Medical Research Council trials.

Blood. 2010 22;116(3):354-65.

Lambert JR, Bomanji JB, Peggs KS, Thomson KJ, Chakraverty RK, Fielding AK, Kottaridis PD, Roughton M, Morris EC, Goldstone AH, Linch DC, Ell PJ, Mackinnon S.

Prognostic role of PET scanning before and after reducedintensity allogeneic stem cell transplantation for lymphoma.

Blood. 2010 Apr 8;115(14):2763-8.

Lowry L, Hoskin P, Linch D.

Developments in the management of Hodgkin's lymphoma.

Lancet. 2010 Mar 6;375(9717):786-8.

Mead AJ, Thomson KJ, Morris EC, Mohamedbhai S, Denovan S, Orti G, Fielding AK, Kottaridis PD, Hough R, Chakraverty R, Linch DC, Mackinnon S, Peggs KS.

HLA-mismatched unrelated donors are a viable alternate graft source for allogeneic transplantation following alemtuzumabbased reduced-intensity conditioning.

Blood. 2010 Jun 24;115(25):5147-53.

Quezada SA, Simpson TR, Peggs KS, Merghoub T, Vider J, Fan X, Blasberg R, Yagita H, Muranski P, Antony PA, Restifo NP, Allison JP.

Tumor-reactive CD4(+) T cells develop cytotoxic activity and eradicate large established melanoma after transfer into lymphopenic hosts.

J Exp Med. 2010 Mar 15;207(3):637-50.

Snowden J, Pettitt A, Clark R, Hale G, Peggs K, Thomson K, Morris E, Mackinnon S.

Impact of in vivo alemtuzumab dose before reduced intensity conditioning and HLA-identical sibling stem cell transplantation: pharmacokinetics, GVHD, and immune reconstitution.

Blood. 2010 Oct 21;116(16):3080-8.

Thomson KJ, Morris EC, Milligan D, Parker AN, Hunter AE, Cook G, Bloor AJ, Clark F, Kazmi M, Linch DC, Chakraverty R, Peggs KS, Mackinnon S.

T-cell-depleted reduced-intensity transplantation followed by donor leukocyte infusions to promote graft-versus-lymphoma activity results in excellent long-term survival in patients with multiply relapsed follicular lymphoma.

J Clin Oncol. 2010 Aug 10;28(23):3695700.

38

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Academics, Research and Clinical Trials

Author

Title

Publication

Anderson K, Lutz C, van Delft FW, Bateman CM, Guo Y, Colman SM, Kempski H, Moorman AV, Titley I, Swansbury J, Kearney L, Enver T, Greaves M.

Genetic variegation of clonal architecture and propagating cells in leukaemia.

Nature. 2011 Jan 20;469(7330):356-61.

Amary MF, Damato S, Halai D, Eskandarpour M, Berisha F, Bonar F, McCarthy S, Fantin VR, Straley KS, Lobo S, Aston W, Green CL, Gale RE, Tirabosco R, Futreal A, Campbell P, Presneau N, Flanagan AM.

Ollier disease and Maffucci syndrome are caused by somatic mosaic mutations of IDH1 and IDH2.

Nat Genet. 2011 Nov 6;43(12):1262-5.

Bolli N, Payne EM, Rhodes J, Gjini E, Johnston AB, Guo F, Lee JS, Stewart RA, Kanki JP, Chen AT, Zhou Y, Zon LI, Look AT.

cpsf1 is required for definitive HSC survival in zebrafish.

Blood. 2011 Apr 14;117(15):3996-4007.

Boshoff C.

Unraveling virus-induced lymphomagenesis.

J Clin Invest. 2011 Mar;121(3):838-41.

Carpenter L, Malladi R, Yang CT, French A, Pilkington KJ, Forsey RW, Sloane-Stanley J, Silk KM, Davies TJ, Fairchild PJ, Enver T, Watt SM.

Human induced pluripotent stem cells are capable of B-cell lymphopoiesis.

Blood. 2011 Apr 14;117(15):4008-11.

Catlin SN, Busque L, Gale RE, Guttorp P, Abkowitz JL.

The replication rate of human hematopoietic stem cells in vivo.

Blood. 2011 Apr 28;117(17):4460-6.

Goardon N, Marchi E, Atzberger A, Quek L, Schuh A, Soneji S, Woll P, Mead A, Alford KA, Rout R, Chaudhury S, Gilkes A, Knapper S, Beldjord K, Begum S, Rose S, Geddes N, Griffiths M, Standen G, Sternberg A, Cavenagh J, Hunter H, Bowen D, Killick S, Robinson L, Price A, Macintyre E, Virgo P, Burnett A, Craddock C, Enver T, Jacobsen SE, Porcher C, Vyas P.

Coexistence of LMPP-like and GMP-like leukemia stem cells in acute myeloid leukemia.

Cancer Cell. 2011 Jan 18;19(1):138-52.

Green CL, Evans CM, Zhao L, Hills RK, Burnett AK, Linch DC, Gale RE.

The prognostic significance of IDH2 mutations in AML depends on the location of the mutation.

Blood. 2011 14;118(2):409-12.

Gutierrez A, Grebliunaite R, Feng H, Kozakewich E, Zhu S, Guo F, Payne E, Mansour M, Dahlberg SE, Neuberg DS, den Hertog J, Prochownik EV, Testa JR, Harris M, Kanki JP, Look AT.

PTEN mediates Myc oncogene dependence in a conditional zebrafish model of T cell acute lymphoblastic leukemia.

J Exp Med. 2011 Aug 1;208(8):1595-603.

39

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Academics, Research and Clinical Trials

Author

Title

Publication

Payne EM, Bolli N, Rhodes J, Abdel-Wahab OI, Levine R, Hedvat CV, Stone R, Khanna-Gupta A, Sun H, Kanki JP, Gazda HT, Beggs AH, Cotter FE, Look AT.

Ddx18 is essential for cell-cycle progression in zebrafish hematopoietic cells and is mutated in human AML.

Blood. 2011 28;118(4):903-15.

Peggs KS, Kayani I, Edwards N, Kottaridis P, Goldstone AH, Linch DC, Hough R, Morris EC, Fielding A, Chakraverty R, Thomson KJ, Mackinnon S.

Donor lymphocyte infusions modulate relapse risk in mixed chimeras and induce durable salvage in relapsed patients after Tcell-depleted allogeneic transplantation for Hodgkin's lymphoma.

J Clin Oncol. 2011 Mar 10;29(8):971-8.

Quinn J, Glassford J, Percy L, Munson P, Marafioti T, Rodriguez-Justo M, Yong K.

APRIL promotes cell-cycle progression in primary multiple myeloma cells: influence of D-type cyclin group and translocation status.

Blood. 2011 Jan 20;117(3):890-901.

Quezada SA, Peggs KS, Simpson TR, Allison JP.

Shifting the equilibrium in cancer immunoediting: from tumor tolerance to eradication.

Immunol Rev. 2011 May;241(1):104-18.

Swerdlow AJ, Higgins CD, Smith P, Cunningham D, Hancock BW, Horwich A, Hoskin PJ, Lister TA, Radford JA, Rohatiner AZ, Linch DC.

Second cancer risk after chemotherapy for Hodgkin's lymphoma: a collaborative British cohort study.

J Clin Oncol. 2011 Nov 1;29(31):4096104.

Thomson KJ, Morris EC, Milligan D, Parker AN, Hunter AE, Cook G, Bloor AJ, Clark F, Kazmi M, Linch DC, Chakraverty R, Peggs KS, Mackinnon S.

T-cell-depleted reduced-intensity transplantation followed by donor leukocyte infusions to promote graft-versus-lymphoma activity results in excellent long-term survival in patients with multiply relapsed follicular lymphoma.

J Clin Oncol. 2010 Aug 10;28(23):3695700.

Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N, Shpilberg O, Dührsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Brière J, Salles G, Moskowitz CH, Glass B.

Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large Bcell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma.

J Clin Oncol. 2012 Dec 20;30(36):4462-9.

Moorman AV, Schwab C, Ensor HM, Russell LJ, Morrison H, Jones L, Masic D, Patel B, Rowe JM, Tallman M, Goldstone AH, Fielding AK, Harrison CJ.

IGH@translocations, CRLF2 deregulation, and microdeletions in adolescents and adults with acute lymphoblastic leukemia.

J Clin Oncol. 2012 Sep 1;30(25):3100-8.

Payne EM, Virgilio M, Narla A, Sun H, Levine M, Paw BH, Berliner N, Look AT, Ebert BL, Khanna-Gupta A.

L-Leucine improves the anemia and developmental defects associated with Diamond-Blackfan anemia and del(5q) MDS by activating the mTOR pathway.

Blood. 2012 Sep 13;120(11):2214-24.

Pina C, Fugazza C, Tipping AJ, Brown J, Soneji S, Teles J, Peterson C, Enver T.

Inferring rules of lineage commitment in haematopoiesis.

Nat Cell Biol. 2012 Feb 19;14(3):287-94.

40

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Academics, Research and Clinical Trials

Author

Title

Publication

Swerdlow AJ, Cooke R, Bates A, Cunningham D, Falk SJ, Gilson D, Hancock BW, Harris SJ, Horwich A, Hoskin PJ, Linch DC, Lister TA, Lucraft HH, Radford JA, Stevens AM, Syndikus I, Williams MV.

Breast cancer risk after supradiaphragmatic radiotherapy for Hodgkin's lymphoma in England and Wales: a National Cohort Study.

J Clin Oncol. 2012 Aug 1;30(22):2745-52.

Thomson KJ, Mackinnon S, Peggs KS.

CMV-specific cellular therapy for acute myeloid leukemia?

Blood. 2012 Jan 26;119(4):1088-90;

Townsend W, Linch D.

Hodgkin's lymphoma in adults.

Lancet. 2012 Sep 1;380(9844):836-47.

Allen C, Hills RK, Lamb K, Evans C, Tinsley S, Sellar Frcpath R, O'Brien M, Yin JL, Burnett AK, Linch DC, Gale RE.

The importance of relative mutant level for evaluating impact on outcome of KIT, FLT3 and CBL mutations in core-binding factor acute myeloid leukemia.

Leukemia. ahead of print]

Cunningahm D, Hawkes EA, Jack A, Qian W, Smith P, Mouncey P, Pocock C, Ardeshna KM, Radfrod JA, McMillan A, Davies J, Turner D, Kruger A, Johnson P, Gambell J, Linch DC

Rituximab plus CHOP in newly diagnosed Diffuse Large B-cell Lymphoma: a phase III comparison of dose intensification with 14 day versus 21 day cycles

Lancet. 2013 25;381

Jenkinson S, Koo K, Mansour MR, Goulden N, Vora A, Mitchell C, Wade R, Richards S, Hancock J, Moorman AV, Linch DC, Gale RE.

Impact of NOTCH1/FBXW7 mutations on outcome in pediatric Tcell acute lymphoblastic leukemia patients treated on the MRC UKALL 2003 trial.

Leukemia. 2013;7(1):41-7

Thomson KJ, Kayani I, Ardeshna K, Morris EC, Hough R, Virchis A, Goldstone AH, Linch DC, Peggs KS.

A response and PET scan dependent transplantation strategy delivers favourable outcomes in primary resistant and relapsed Hodgkin Lymphoma: implications for front line therapy

Leukemia. 2013 [Epub ahead of print]

TylerR.Simpson, Fubin Li, Welby Montalvo-Ortiz, Manuel A. Sepulveda, Katharina Bergerhoff, Frederick Arce, Claire Roddie, Jake Y. Henry, Hideo Yagita, Jedd D. Wolchok, Karl S. Peggs, Jeffrey V. Ravetch, James P. Allison and Sergio A. Quezada.

Fc-dependent depletion of tumor-infiltrating regulatory T cells codefines the efficacy of anti-CTLA-4 therapy against melanoma.

J. Exp Med. 2013

41

[Epub

Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

6.

Delivering a New Pathway for Patients with Haematological Cancer

6.1.

This section of our application outlines the leadership and pathway for patients with haematological cancer and demonstrates how we meet the specified requirements of London Cancer. The parameters from the service specification have been used in order to structure the response.

Leadership 6.2.

The HSCT and Acute Leukaemia services are contained within the wider Department of Haematology, containing both clinical and academic elements. Leadership is provided at various levels across the department and wider Cancer Services Division, and from within the UCL Cancer Institute, and close collaboration between different aspects of the service has been and remains key to the sustained excellence of the service.

6.3.

The leadership structure for the Department of Haematology at UCLH and UCL comprises:

Academic Lead and Head of Department: Professor David C Linch (Professor of Haematology and Honorary Consultant, Chairman of CRUK Cancer Centre at UCL and Cancer Programme Director for NIHR Biomedical Research Centre (BRC) at UCL/UCLH)

Clinical Lead for Haematology: Dr Kirsty Thomson (Consultant and Honorary Senior Lecturer- Programme Director for HSCT at UCLH; Medical Director for Harvesting Facility at UCH)

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Clinical Lead for Cancer Centre: Dr Kirit Ardeshna (Consultant and Honorary Senior Lecturer- Pathway Director for Haematological Malignancy for London Cancer; Medical Advisor for Lymphoma Association; member of Haemato-oncology task force for BCSH; member of NCRI Lymphoma clinical studies subgroup)

Nursing: Mr Stephen Rowley (Divisional Senior Nurse/Matron for Haematology- Chairman Leukaemia & Lymphoma Charity; Clinical Director for the Association for Safe Aseptic Practice- a non profit organisation involved in standardising aseptic technique internationally).

6.4.

Within the clinical department, there are disease-specific leads. Regarding the current and future direction of the HSCT and Acute Leukaemia services, the continuing development of these programmes will require coordination of both academic and clinical interests here at UCLH via Professor David Linch and Dr Kirsty Thomson - within the wider strategy of the Trust and University- and input from other stakeholders within the sector, for example via ongoing joint consultant posts with referring centres. Key additional personnel within these specific services at UCL/UCLH are as follows:

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Haematopoietic Stem Cell Transplantation

Dr Karl Peggs (Reader in Stem Cell Transplantation and Immunotherapy and Honorary Consultant; member of NCRI Lymphoma Clinical Studies Group, NCRI Haematological Oncology Clinical Studies Group, Scientific CoChair of the British Society of Blood and Marrow Transplantation (BSBMT), member of the BSBMT Clinical Trials Committee, member of the Anthony Nolan Medical Advisory Board and Research Pathway Lead for London Cancer Pathway Board for Haematological Malignancies; Trustee of the Teens Unite charity)

Dr Emma Morris (Reader in Immunology and Honorary Consultant in Stem Cell Transplantation; Director of Research & Development, RFH ; National Executive Committee Member, BSBMT; Board Member, BSGCT; Chair, UCL Clinical Research Governance Committee; Chair, Joint UCL, UCLH and RFH GM Safety Committee (Clinical Trials); Immunotherapy Lead, UCL Experimental Cancer Medicine Centre; Board Member, UCL Experimental Cancer Medicine Centre; Member, UCL Research Governance Committee; Editorial Board, BJ Haem)

Dr Rachael Hough (Consultant and Honorary Senior Lecturer; Lead Clinician for TYA Cancer at UCLH; CoChair for Children and Young People’s Cancer, London Cancer; Chair of TYA CRG ; Chair of BSBMT Cord Blood Working Group; National TYA coordinator of UKALL2011; Member of NCRI Children’s Leukaemia Subgroup, Adult ALL Working Group, BSBMT Clinical Trials Committee, All Party Parliamentary Group on Stem Cells, TYAC Research and Registration Subgroup, DoH Stem Cell Strategic Forum Oversight Committee and Stem Cell Supply Group).

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Acute Myeloid Leukaemia-

Professor Asim Khwaja (Professor of Haematology and Honorary Consultant- lead clinician for adult Acute Leukaemia at UCLH; Lead for Young Adult Leukaemia on the UCLH TYA MDT; Member of the UK National Cancer Institute Working Group in AML and Clinical Coordinator of the upcoming national AML18 Trial; Member of the Cancer Research UK New Agents Committee; ex-Member of the Leukaemia Research Fund Clinical Trials Advisory Panel (2000 – 2008) and of the National Cancer Research Network Haematological Oncology Clinical Studies Group (2009 – 2012); Clinical Advisor and Speaker for Leukaemia Care; Chief Advisor and provider of content for Leukaemia section of Healthtalkonline, an award-winning website that provides reliable expert information and shares patient experiences). 6.5.

There is therefore a wealth of experience, both clinical and academic, at local, national and international level within the Department. If UCLH was selected as one of the two providers of HSCT, then clearly there would be detailed discussions with the provider no longer performing HSCT, regarding the future structure of the service and wider department at UCLH. These discussions would be complex, and would involve the clinical departments and broader divisions from both sites, the academic department at UCL both within and beyond the Cancer Institute, nursing leadership, the directors of the Processing Facilities and managerial input from both sites. Discussions would also involve collaborative interaction with other providers within the sector, to ensure seamless implementation of the altered patient pathways.

6.6.

At UCLH, this would be led by Professor David Linch. Professor Linch has held a Chair in Haematology at UCL since 1988, and has been Head of the Department of Haematology since 1992. He has successfully overseen the development of the department into the large and productive unit that it is today - strong in both basic science and translational research and clinically excellent - by recruiting a series of key academic clinicians. He has a national and international reputation in his own area of clinical interest, Hodgkin lymphoma, and has been prominent in laboratory research in the field of myelopoiesis and myeloid leukaemias and in clinical research in the field of high dose therapy strategies in leukaemia and lymphomas.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

6.7.

Leadership/Patient Pathway/Joint Working

Beyond the Department, Professor Linch has leadership experience as Chairman of the Division of Cancer Medicine at UCL (2004-2007), and is currently Chairman of CRUK Cancer Centre at UCL, Cancer Programme Director for NIHR Biomedical Research Centre (BRC) at UCL/UCLH and Director of the Lymphoma Trials Office. He has also demonstrated leadership at a national level, as President of the British Society of Haematology, Chairman of the NCRI Lymphoma Clinical Studies Group and Chairman of the Medical Research Council Leukaemia Trials Steering Committee. He is the President of the Lymphoma Association, a national patient advisory and support organisation, and has served on numerous advisory bodies including the Scientific Committee and the Clinical Trials Committee of the Leukaemia Research Fund, the Medical Advisory Panel, the Cell and Molecular Panel and International Panel of the Wellcome Trust.

6.8.

Professor Linch has also been instrumental in developing and maintaining strong links with partner hospitals and services. These include the establishment of close working with the Haematology service at the RFH, and joint consultant appointments in Haematology with the Whittington Hospital, North Middlesex Hospital, and Barnet Hospital. He has supported the development and consolidation of the early phase trials programme in haematology in the CRF, with the appointment of a new dedicated early phase trials consultant post, aimed at building a portfolio of trials in haematological malignancy both on this site and with partner organisations. He has also established a new consultant post as a joint undertaking with the Division of Pathology at UCLH, in order to create a laboratory/thrombosis and haemostasis post.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Patient Pathway 6.9.

These pathways involve the referral of patients at varying stages of disease treatment, depending on disease type, stage and response to induction or salvage chemotherapy. Key elements are prompt and accurate diagnosis, appropriate referral to the centre, well-established lines of communication between UCLH and referring hospitals, early involvement of patients in the management discussions and a programme of effective education/information regarding the proposed treatment.

6.10. For this to function optimally, there needs to be an effective and rapid diagnostic service, access to an MDT with appropriate specialist representation, uniformity of management protocols across the sector including triggers for referral to the centre, strong working relationships between healthcare personnel and ready availability of CNS staff. 6.11. For example in HSCT, early involvement of HSCT CNSs is critical, and allows the establishment of dialogue with the patient and family and with counterpart staff at the referring centre. The CNS can ensure the process of informing and educating the patient occurs at a time and pace suited to the individual, and can coordinate assessments/clinic appointments at UCH, in order to minimise travel. After transplant, clear instructions to patients about triggers for seeking medical help, lifestyle advice and simple reliable contact details are crucial. 6.12. Ready access to counselling and other support services including palliative care or symptom control teams at an appropriate stage is also required. For follow-up, an agreed model of shared care should be adopted, striking an appropriate balance between delivering care near home where possible, and not jeopardizing outcome by sending patients early post-HSCT back to non-HSCT centres for treatment of complex procedure-related problems. Optimal arrangements depend on patient and procedure characteristics, and the expertise and experience of the clinicians involved.

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Improving Services for Haematological Cancer Services : UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Allogeneic HSCT Pathway External referral Patient diagnosed +/-undergoing therapy at referring centre (level 1, 2a, 2b)

Decision to recommend alloHSCT may occur peri-dx or may be at subsequent point in pathway

Internal referral Patient diagnosed +/- undergoing therapy at UCH

MDT Review Relevant MDT with transplant clinician +/- UCH specialty clinic or UCH in-patient facility

MDT decision Allogeneic HSCT recommended treatment or potential treatment option e.g. depending on disease response, further diagnostic information

HSCT CNS team maintain close links with specialty team/referring team and patient during period of on-going treatment/ repeat assessments/MDTs to update on progress and keep informed

HSCT CNS team arrange tissue-typing of patient and donor search. Contact made with patient, education process commenced. Siblings contacted by related donor CNS, as appropriate.

HSCT clinicians liaise with referring clinicians Consultation with patient re options and recommendations at this stage

Patient added to HCST MDT for weekly discussion until admission for HSCT or alternative pathway chosen

Further treatment/restaging/MDT discussion(s) Donor identified

Decision to proceed with allogeneic HSCT Protocol finalised Referral to radiotherapy if TBI-containing protocol Final recipient work-up (e.g. organ function assessment; dental review) Donor called up

HSCT clinic review HSCT clinician and CNS consult with recipient and family; consent to procedure +/- trial Clinical oncology clinic review

Weekly update to referring clinician

ALLOGENEIC HSCT

HSCT outpatient clinic (~100 days): Early complications- GVHD, infection, initial morbidity

HSCT outpatient clinic (>100 days): Ongoing assessment for procedure-related complications, plus monitoring for disease status Late effects/ fertility issues/MSIS. +/- shared care as agreed with patient/referring centre

48

HSCT CNS regular contact while I/P

Improving Services for Haematological Cancer Services : UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Autologous HSCT Pathway External referral Patient diagnosed +/-undergoing therapy at referring centre (level 1, 2a, 2b)

Decision to recommend autoHSCT may occur peri-dx or may be at subsequent point in pathway

Internal referral Patient diagnosed +/- undergoing therapy at UCH

MDT review Relevant MDT with transplant clinician/UCH specialty clinic / UCH in-patient facility

MDT Decision Autologous HSCT recommended treatment or potential treatment option e.g. depending on disease response, further diagnostic information

HSCT CNS team maintain close links with specialty team/referring team and patient during period of ongoing treatment/ repeat assessments/MDTs

Post MDT, clinicians liaise with referring centre. Consultation with patient re options and recommendations at this stage. HSCT CNS team commence education process

Patient added to HCST data base

Further treatment/restaging/MDT discussion(s) as required

Decision to proceed with autologous HSCT Protocol finalised Referral to radiotherapy if TBI-containing protocol

Specialty clinic review Clinician and CNS consult with recipient; consent to harvesting procedure +/- trial where appropriate

Weekly update to referring clinician HSCT CNS rmaintains regular contact while I/P

Recipient work-up Mobilisation regimen administered, apheresis performed Final recipient work-up (e.g. organ function assessment; dental review)

Autologous HSCT admission Via ambulatory care service where indicated

Autologous HSCT outpatient clinic Assessment for early complications, then monitoring for disease status at 100days. Late effects/ fertility issues/MSIS. Model of shared care with referring centre

49

If mobilisation inadequate, follow plerixafor pathway follow plerixafor pathway

Improving Services for Haematological Cancer Services : UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Acute Myeloid Leukaemia Pathway (Intensive Treatment)

Secondary Care Level 1 and 2a refer to UCH Abnormal blood count and suspicion of leukaemia

Direct Admission to Ward Trust phones GP directly with abnormal blood result and suggests that patient is admitted to ward

Primary Care Assessment Abnormal blood count / suspicion of acute leukaemia

Emergency Presentation via A&E

Referral Urgent referral from GP with suspicion of leukaemia. Received by Trust and contacted immediately.

First seen in Clinic / Day Unit / Ward Review / Admission Referred from level 1 or 2a within 24 – 48 hrs to UCH

Investigations Bone marrow, immunophenotyping, cytogenetics, FISH, trephine and MRD samples Non-Malignant diagnosis – further management as appropriate

Consider urgent leukophoresis Confirmation of Diagnosis Management decision at Specialist MDT or Specialist MDT approved method for urgent treatment

Consultation and Management Plan -decision to recommend intensive treatment

Patient information given: Consider trial, Tissue type patient and siblings if appropriate, Fertility preservation as indicated. Holistic needs assessment, PICC line, Organ function assessment as indicated

Weekly update to referring clinician

First Treatment Consent, administer induction chemotherapy

MDT to monitor bone marrow response

If disease proves refractory, appropriate end of life care/involvement of Macmillan services, GP

Further Treatment - consolidation chemotherapy - consider ambulatory care - consideration of transplant if criteria other than inadequate response to induction met (e.g. standard risk with HLA-matched sibling; high risk cytogenetics etc)

Follow-up AML -regular monitoring in OPD at decreasing interval -institution of shared care/transfer back to referring centre at patient/clinician(s) discretion

Survivorship End of treatment summary/HNA Late effect review/survivorship

If response postinduction inadequate, planned alteration of treatment and enter stem cell transplant pathway

Follow-up APML -bone marrow residual disease monitoring 3 monthly for 3 years (consider also for core binding factor AML) - regular OPD visits as for AML

Relapse Work up to confirm, refer back to MDT

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

Joint Working with Other Hospitals 6.13. The provision of services for complex treatment of haematological malignancy requires close and effective working relationships between UCLH and its referring centres. The model fostered at this site in recent years has been a combination of videoconference-linked disease-specific MDTs with referring hospitals in the sector and beyond, joint consultant appointments and UCLH consultants attending clinics at other sites. 6.14. Our experience of joint appointments at consultant level is extremely positive. This facilitates good communication between individuals by virtue of shared working on the UCLH site, and promotes uniformity of protocol

Chase Farm Hospital

use and referral practice in patients requiring level 3 care, with prompt and appropriate referral a particular strength. It also helps to maintain expertise in the referring centres, which is an important issue for the provision of local care in a shared care model. This maximises the opportunity for care to be

North Middlesex Hospital

Barnet Hospital

delivered locally wherever possible, and provides a solid base for dealing with the emergency admissions which occur on an ad hoc basis. Finally, it optimises access for patients in referring centres to the full portfolio of clinical trials open on the UCLH site. 6.15. Current MDT links (either videoconferencing or with joint appointee present in person) exist with Mount Vernon Hospital, Whittington Hospital, Barnet

UCLH Royal National Orthopaedic Hospital

The Whittington Hospital

and Chase Farm Hospitals, East Surrey Hospital, North Middlesex Hospital and Luton and Dunstable Hospital.

Luton & Dunstable Hospital

51

Mount Vernon Cancer Centre

Improving Services for Haematological Cancer: UCLH Application to London Cancer

Leadership/Patient Pathway/Joint Working

6.16. Referrals for consideration of HSCT also come from a variety of other units with which UCLH has strong links (Ashford and St Peter’s Hospital, Frimley Park Hospital, Worthing Hospital, Colchester Hospital, Basildon Hospital). Clinicians from the referring centres are not present at the MDT(s), but there is inter-consultant communication before and after, and the patients are reviewed at the appropriate specialty clinic at UCH. 6.17. Joint consultant appointments currently in place between UCLH and partner hospitals are as follows: Dr Neil Rabin- North Middlesex Hospital/ UCLH (myeloma) Dr Saj Mohammedhbai- North Middlesex Hospital/UCLH (lymphoma) Dr Shirley D’Sa- Mount Vernon Hospital/UCLH (Waldenstroms Macroglobulinemia, myeloma) Dr Jon Lambert- Mount Vernon Hospital/UCLH (lymphoma) Dr Andres Virchis- Barnet and Chase Farm Hospitals/UCLH (lymphoma) Dr Rahul Joshi- Luton and Dunstable Hospital/UCLH (lymphoma) Dr Ching Cheung- Luton and Dunstable Hospital/UCLH (lymphoma) Dr Ali Rismani- Whittington Hospital/UCLH (myeloma)

6.12 UCLH clinicians attend clinics at partner hospitals as follows: Professor Asim Khwaja- malignant haematology clinic at Luton and Dunstable Hospital Dr Shirley D’Sa- Joint paraprotein/neuropathy clinic (National Hospital for Neurology and Neurosurgery) and joint clinic with interventional radiologists for skeletal disease in plasma cell disorders (Royal National Orthopaedic Hospital). 6.18. The following table provides an example of a current consultant job plan: Day

Monday am

Time

Hospital/

(From – To)

Location

8.00 –12.00

UCLH

Type of Work

Classification of Activity

No. of PAs

MDM (myeloma)

DCC

0.75 UCLH

Management/Audit

SPA

0.25 UCLH

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Day

Monday pm

Time

Hospital/

(From – To)

Location

1.30. – 2.00

NMUH

Type of Work

Classification of Activity

No. of PAs

Radiology MDM

DCC

1.0 NMUH

Ward Round

DCC

NMUH

Teaching & Training

SPA

0.25 NMUH

UCLH

CRF clinic

DCC

1.0 UCH

Research/CPD/teaching

SPA

0.5 UCH

Laboratory / Clinic letters & administration

DCC

1.0 NMUH

MDM (haem malig)

DCC

2.00 – 5.30

Monday eve Tuesday am

8.00 – 1.00

Leadership/Patient Pathway/Joint Working

Trial documentation

Tuesday pm

1.00 – 5.00

NMUH

Tuesday eve Wednesday am

8.00 – 1.00

UCLH

Myeloma trials / autograft clinic

DCC

1.25 UCLH

Wednesday pm

1.00. – 6.00

UCLH

Research / CPD

SPA

1.25 UCLH

Thursday am

9.00 – 1.00

UCLH

Myeloma clinic

DCC

1.0 UCLH

Thursday

2.00 – 3.00

UCLH

Clinical Admin / letters

DCC

0.25 UCLH

3.00 – 5.00

UCLH

MDM (leukaemia & lymphoma)

DCC

0.5 NMUH

Wednesday eve

pm

Thursday eve

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Day

Time

Hospital/

(From – To)

Location

Leadership/Patient Pathway/Joint Working

Type of Work

Classification of Activity

No. of PAs

Friday

am

9.00 –1.00

NMUH

General/myeloma clinic

DCC

1 NMUH

Friday

pm

1.00 – 2.00

NMUH

Admin/Letters

DCC

0.25 NMUH

Management/Adm

SPA

0.75 NMUH

DCC

8.5

SPA

2.5

2.00 – 5.00 Total PAs

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Local Services/ Transport

7.

Maintaining Local Access and Enabling Patient Transport

7.1.

If UCLH is successful in its application to host Haematological Cancer Services, we will ensure that for those patients who do have to travel to UCLH we will do our best to support the provision of efficient and convenient transport arrangements.

Local Services 7.2.

Maintaining the strengths and expertise of local services is vital. Delivering high quality care in complex pathways requires a balance between providing care near the patient’s home, and ensuring care requiring specific expertise is provided at the centre. At appropriate points in the pathway, both during active treatment and in longer term follow-up, local care may be delivered in a planned way, but where patients are best served by receiving treatment in the centre, this should occur. For example, immediate care post-HSCT for allogeneic transplant care is best delivered at the centre, because of the complex nature of the issues at this stage. Discussing the rationale for this with patients is vital, for example to explain why delivery of an allogeneic transplant is only partially completed during the initial admission, and the short/medium term aftercare may form as critical a part of the therapy as the transplant procedure itself.

7.3.

Other than planned shared care, the other key area where local services are of significant importance is for emergency care. All patients are given clear information regarding contact numbers for haematology at UCLH (both in and out of working hours) and therefore have 24 hour access to trained haematology staff. Where appropriate, arrangements are made for review at UCLH, but there are situations where local review is preferable or inevitable, e.g. if patients are sufficiently unwell that they require to be admitted immediately from home via emergency ambulance to the nearest A&E. While prompt transfer to the centre will be facilitated, it is clearly invaluable if the local hospital has haematology clinicians with the knowledge and experience to give on site input on an individual basis. Beyond this, the presence of such staff assists in ensuring a strong acute oncology service is built and maintained at such local hospitals.

7.4.

The joint working practices detailed in Section 6 ensure uniformity of practice, excellent working relationships between clinicians, clear lines of communication and maintenance of clinical expertise at referring units.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Local Services/Transport

Transport 7.5.

Whilst this section demonstrates the accessibility of the UCLH sites, we recognise the genuine concerns that patients have expressed about the need to improve transport services for patients attending the Cancer Centre at UCLH. We will work with London Cancer and the Cancer Partnership Boards to identify innovative solutions to these problems.

7.6.

UCLH is building on the UCLP’s patient transport services specification in the current review of our transport strategy in consultation with Camden Council. As part of these discussions, we will be asking Camden Council to make available space for an increased number of disabled car parking bays in the immediate vicinity of UCLH. However, in line with the transport policies of the Mayor for London and Camden Council, UCLH will not be encouraging patients to attend outpatient appointments using their own private transport that would require local car parking. Public transport links to UCLH are excellent; eligible patients and families will of course continue to receive reimbursement of their travel costs in line with national eligibility rules.

Patient Transport 7.7.

There are distinct transport arrangements for patients who have received allogeneic HSCT. This reflects their particular susceptibility to infection in the period following their discharge. Viral infections can be extremely serious and precautions to prevent close contact in enclosed spaces with people who may have such infections must be taken wherever possible. It is also acknowledged that they may be generally debilitated and arrangements are made to permit an escort in the initial phase. Transport guidance reflects this, as follows: For Allografts: Patients are entitled to transport for first 12 weeks post discharge Weeks 1-4 o Exclusive use with escort Weeks 5-8 o

Exclusive use no escort unless medically unfit to travel alone Weeks 9-12

o Shared transport

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Local Services/Transport

Patients may remain on transport beyond 12 weeks if deemed medically unfit to travel by any other means. The assessment is performed by the transplant clinicians. For Autografts: Patients are entitled to transport to take them home on discharge from hospital following their transplant. Patients are then entitled to subsequent hospital transport if medically unfit to travel by any other means; and are required to call the transport assessment team who perform a short assessment about their clinical condition.

7.8.

We acknowledge the need to further improve the booking arrangements for cancer patients using NHS transport for journeys to the UCLH campus and back home in order to ensure that the timing is convenient and suitable for patients and their families. This is one specific area where we will work with the Cancer Partnership Boards on the best ways to achieve the necessary improvements.

7.9.

UCLH is currently producing an overarching travel plan policy which will govern Trust-wide measures, initiatives and monitoring over the next five years. This travel plan is designed to enable the staff, patients and visitors of UCLH to make more informed decisions about their travel. We are also in the process of assessing the quality of the existing hospital patient transport service and will ensure that patients are transported in suitable vehicles, with appropriate standards of timeliness and comfort, equipped where required to provide appropriate levels of care.

Public Transport 7.10. The site has extensive public transport options due to its Central London location.

Buses 7.11. UCLH is very well served by buses, with a number of routes being accessible from within a 600m walking distance of the campus. Between them, these routes provide bus services across Greater London.

Underground 7.12. UCLH is located within walking distance from three London Underground stations: approximately one minute walk to both Warren Street to the west (100m), and to Euston Square to the east (200m) and approximately five minutes’ walk to Euston (600m) also to the east. Between them, these stations provide easy access to the Victoria, Northern, Circle, Hammersmith & City and Metropolitan lines.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Local Services/Transport

Mainline Rail Services 7.13. Euston mainline station is approximately 600m away from the site. The station offers frequent services on the West Coast Mainline and London Midland to Manchester, Birmingham and Liverpool as well as long distance commuter destinations such as Tring, Milton Keynes and Northampton. In addition, King’s Cross and St. Pancras Stations are approximately 1.2km away from the site. These stations offer frequent services on the Midland and East Coast main lines to destinations to the north and south of London, including Luton and Gatwick Airports. Euston, King’s Cross and St. Pancras Stations all offer cycle parking and step-free access for mobility impaired travellers.

Private Transport 7.14. The area surrounding the UCLH sites encompasses major arterial routes, including Euston Road (A501) to the north, Gower Street (A400) to the east and Tottenham Court Road (A400) to the west. 7.15. Car parking provision at UCLH sites is very limited but UCLH is pledging as part of the bid to support as much clinical care as possible is delivered at local hospitals to prevent the need to drive to the hub and when travel to the hub is necessary to ensure that the number of visits is limited as far as possible.

Travel Times 7.16. The maps demonstrate the approximate travel times by car (black text) and by public transport (green text) to UCLH from the other London Cancer hospitals.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Local Services/Transport

59

Improving Services for Haematological Cancer: UCLH Application to London Cancer

Audit of Outcomes & Experience

8.

Improving Patients’ Outcomes and Experience

8.1.

We recognise the importance of measuring and publishing information on outcomes and experience for patients within the Haematological Cancer Service and are committed to maximising and improving the outcomes and experience for patients.

Audit and Outcomes Clinical Outcomes 8.2.

The graphs below reflect national benchmarking from 2012. The data was generated by the registry staff at the British Society of Blood and Marrow Transplantation (BSBMT) with partial funding from the commissioners of HSCT. The data reports overall survival at one year post-HSCT, for a cohort of patients transplanted during a five year period. The reason for the five year period is that the numbers for any individual year are considered too small to give meaningful output. The procedures are split into autologous and allogeneic transplants, because of the substantially different risk involved in the two classes of procedure. Each centre (UCLH is centre 224) is then benchmarked against the national outcomes. In both figures, the UCH survival curve is the red line (with dotted 95% confidence limits) and the grey line is the national survival curve. For both autologous and allogeneic HSCT, UCLH outcomes are favourable.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

8.3.

Audit of Outcomes & Experience

Regarding further reporting of outcomes, the unit at UCL/UCLH regularly publishes outcome data in papers in peer-reviewed journals. This is an excellent and robust method of demonstrating quality, and is a high priority for both the HSCT and the AML programmes. The output is a combination of single centre data, cohort data where UCL/UCLH is the lead centre for a multicentre study, and national/international registry or national trial data where the unit is one of many participants within the UK or across Europe and beyond.

8.4.

UCLH reports data on all transplants undertaken, to the British Society of Blood and Marrow Transplantation and the European Blood and Marrow Transplant. These registries provide a database for national and international collaborative studies. This data is also available to the commissioners of HSCT. UCLH also reports the data required for the National Dashboard Pilot (demographics, immediate and late outcomes).

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Audit of Outcomes & Experience

Clinical local Audits 8.5.

A list of local audits undertaken between April 2012 and March 2013 and action points are listed below: Measuring GFR in Allogeneic Transplant Patients Formal measurement of GFR with EDTA cannot be abandoned in allograft patients as eGFR does not correlated with actual GFR Patient Group Directive (PGD) – Inpatient Neutropenic First Spikes Audit A previous audit undertaken last year found that over 50% of the time first line antibiotics were not administered within 60 miniutes of the first spike of st

fever. Therefore a PGD was approved permitting trained nursing staff to administer the 1 antibiotic (Ceftazidime or Tazocin) in the absence of a medical prescription. An audit of this new system revealed: 81% of patients received antibiotics within 1 hour with no patients waiting over 2 hours. When a PGD has been used antibiotics arrived in 45 minutes or under. When PGD is not used most commonly this is because the SHO has been on the ward or staff did not feel confident in diagnosing neutropenic fever. Recommendations: All first neutropenic spikes to be given PGD even if the SHO is on the ward to bring administration down to under 30 minutes. Currently only Band 6 nurses are PGD trained. Next phase it will be compulsory for all nursing staff. Ambulatory Care (AC) Nurse Led Assessments Audit has shown 24% of patients are staying in AC longer than necessary, 8% of which is because they are waiting for review by a doctor. A nurse led assessment protocol has been implemented to reduce delays by avoiding the need for patients wait to see a doctor Chest X-rays in Neutropenic Sepsis POLICY CHANGE: only patients with respiratory systems or signs or those with changes in respiratory rate or oxygen requirement require a CXR when they first spike a neutropenic fever.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Audit of Outcomes & Experience

Audit Of The Use Of Posaconazole As An Oral Conversion Therapy In The Treatment Of Fungal Chest Infection – Preliminary Results Adherence to guidelines regarding repeat scanning and discontinuation of posaconazole suboptimal. Antibiotic Durations and Indications Audit Data ECG Data for PICC Insertion Use of ECG data is reliable in ensuring the correct PICC tip position and this method will be adopted in the unit rather than the use of check Xrays A Study Into The Utilisation Of Biopsies In The Diagnosis Of GvHD Skin biopsies are unhelpful unless for a specific lesion. Upper GI biopsies are generally uninformative. Lower GI and liver biopsies appear more useful. Stem Cells Stored for Myeloma Patients at UCLH Unused stem cells impact on the storage facilities at UCLH. The majority of patients can be successfully re-mobilised, particularly now that we have access to Plerixafor. We are unable to predict whether patients with stem cells stored will proceed to a second transplant, as follow up is short. Historically only a minority of patients at relapse underwent a second ASCT (approximately 20%).This resulted in a policy change: We should aim to 6

collect a minimum CD34+ stem cell dose of 2 x 10 /kg in patients considered suitable for an ASCT. For patients who collect sufficient stem cells in 6

one day for 2 doses (>4 10 /kg), a second dose may be stored and only half of the cells returned at first ASCT. Patients will not be re-harvested on a second day if their stem cell yield is between 2-4x106/kg. A re-audit in 1 year will be performed, paying particular attention to our ability to re-mobilise patients

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Audit of Outcomes & Experience

Patients’ Experience 8.6.

UCLH recognises the importance of both measuring and publishing information on the outcomes and experience of diagnosis, treatment and supportive care for Haematological Cancer Services.

8.7.

UCLH has introduced real-time surveys in cancer day case, outpatients and inpatients to allow on-going feedback about the services with the data (and responses) reviewed regularly by the staff, as well as monthly through a Cancer Patient Experience Programme. UCLH Chief Executive Sir Robert Naylor has commented: “In the wake of the Francis Report, we support the expectation of greater openness about how we are performing. This new section on our website is just a start: over the next few months we plan to publish more detailed information about the care we provide in a way that patients can easily understand. We want our patients to come to UCLH knowing that they are in the best possible hands”.

8.8.

The cross-division Cancer Patient Experience Programme, that includes both staff and patients, was established in December 2012, supported and agreed by the Executive Board. The programme coordinates action plans across four themes, identified from analysis of the survey results and to improve cancer patient experience: Explanation and involvement of patients in decisions – to include a greater understanding of patients understanding Written information – to improve the quality and availability across the organisation Emotional support – improved access to clinical nurse specialists and the roll out of SAGE & THYME training for staff Always – some basic dos and don’ts for everyone dealing with cancer patients

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

8.9.

Audit of Outcomes & Experience

The National Cancer Patient Experience Survey (NCPES) 2011/2012 published in August 2012, included a number of very positive comments about the haematological service. Samples of these quotes are shown below.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Audit of Outcomes & Experience

8.10. The team also receive on going patient feedback from the local meridian surveys, which although mostly carried out on day case patients include questions about their outpatient visit. These are the results for patients surveyed between November 2012 and June 2013. Cancer Survey – Summary 0% to 70%

Haematology Leukaemia

70% to 80%

80% to 100%

Returns

Always

Explain

Emotional Support

Written information

Waiting time

Your overall NHS care

Radiotherapy and Chemotherapy Treatment

17

86%

86%

88%

97%

83%

86%

90%

-

8.11. Further local specific surveys have been undertaken by the HSCT CNS team covering autograft patients, allograft patients and related donors. A PowerPoint presentation was prepared detailing the process, analysis, results and outcomes of all these surveys (Appendix D). 8.12. Waiting times for outpatients’ clinics are an additional priority area. There is rolling four month data collection of the time waited by each individual patient logged in to clinics. For the two allogeneic transplant clinics that occur each week, average waiting times are 14 and 21 minutes. 8.13. A new Haematology Telephone Line was implemented in July 2012 in order to improve patient experience. The line is staffed Monday to Friday from 09:00 to 17:00. The aim of the phone line is to provide a single point of access for patients, with effective and prompt triage of calls by a small group of trained staff from within the haematology department. Administrative queries for haematology and often other departments are dealt with rapidly by the phone-holders and clinical queries escalated to the nursing or medical teams involved, without delay. The service undergoes a rolling audit, and the first 40 weeks have shown this to be highly successful. Patients have been asked for feedback (written and verbal) and all comments have been positive, the majority of queries are administrative (~75-85%) and dealt with immediately by the phone-holder, and CNS time has been significantly freed up. 8.14. The service also provides a dedicated out of hours telephone advice line that provides general and emergency advice to patients and their carers. This mobile phone is held by a senior ward nurse who works in collaboration with the medical teams. All calls are documented electronically and disseminated to the appropriate CNS for follow up. This permits any patient to speak directly to a trained member of the haematology staff at any time.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Organisational Capacity/Impact of Change

9.

Providing the Capacity to Transform Services

9.1.

The Board of Directors of UCLH have consistently reaffirmed their support to the strategic development of specialist cancer services at UCLH, and to working in partnership with London Cancer to ensure that these improvements benefit the whole population served by London Cancer. The Board’s commitment to the development of cancer services at UCLH has been demonstrated by the opening of the £100 million University College Hospital Macmillan Cancer Centre in April 2012, which includes the provision of excellent modern dedicated facilities for clinical haematology services. The Board have made a further commitment to the development of specialist cancer services by agreeing the Outline Business Case for our Phase 4 development, which will include the proton beam therapy service, due to open in 2018.

Organisational Capacity 9.2.

In line with UCL Partners’ strategic vision, UCLH is working closely with Barts Health and UCL Partners towards the transfer of specialist cardiac services from UCLH to Barts Health early in 2015, subject to the outcome of public consultation. This change will make 90 inpatient beds and 4 inpatient bed theatres available at UCLH. We are also working on longer terms plans to consolidate services when our Phase 4 development, including proton beam therapy, opens in 2018. We expect this to include the provision of up to 150 additional beds in our Phase 4 development, which will allow us to consolidate all of the inpatient services within UCLH onto two sites in 2018 at University College Hospital and at Queens Square.

9.3.

These plans will give us the capacity to develop specialist cancer services for the population of North and East London, including specific application to London Cancer to develop specialist Head and Neck, Upper GI, Thoracic Surgery, and Haematological Cancer Services on the University College Hospital campus, as well as further developments in specialist Brain and Spinal Cancer Services at Queen Square.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Organisational Capacity/Impact of Change

UCLH Proposal for Haematological Cancer Services 9.4.

We will therefore have capacity to transfer all of the HSCT and acute leukaemia work currently undertaken at the RFH, reducing the number of centres undertaking this specialist work to two as proposed in the service specification. We also have the capacity to take on allied work for patients with other haematological malignancies currently carried out at RFH if the advantages of transferring these services are accepted. In line with our strategic capacity plans, the earliest possible date for this transfer will be 2015, as we do not wish to transfer services to UCLH until we have completed and agreed the detailed plan to provide the capacity, in a way that will clearly lead to improvements for patients, and to consolidate the position of UCL and UCLH as the leading provider of haematological services and research for cancer patients in the UK.

9.5.

This transfer of work from RFH to UCLH will require a detailed implementation plan. We propose that this implementation plan should be drawn up in collaboration with RFH, London Cancer, and other NHS Trusts. This plan will comprise three pieces of work: Detailed implementation plan for transfer of services from RFH to UCLH for HSCT, acute leukaemia, and allied services for patients with haematological malignancies Interim operational policy for haematological malignancies at the RFH Working with London Cancer and other NHS trusts

9.6.

We acknowledge that wider discussions about haematology services for non-cancer patients will also need to take place between the Trusts concerned.

Detailed UCLH implementation plan for Haematological Cancer Services 9.7.

We propose that HSCT, acute leukaemia, and allied services should move from RFH to UCLH to improve services, outcomes, and patient experience. More patients will benefit from the excellent facilities at the UCLH Macmillan Cancer Centre, building even closer working relationships between the clinical services and the academic haematology service based at the UCL Cancer Institute, and enabling the population to benefit from the very best services on offer without duplication of costs or facilities between two neighbouring NHS institutions.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

9.8.

Organisational Capacity/Impact of Change

Initial analysis of the RFH activity data indicates that UCLH will be able to accommodate this activity for acute leukaemia, bone marrow transplant and the remainder of their malignant haematology practice in 2015, when cardiac services have transferred from the Heart Hospital to Barts Health. This will free up capacity within this Trust to ensure provision of appropriate, single room, en suite inpatient facilities in the UCH Tower and daycare, apheresis and outpatient space within the UCH Macmillan Cancer Centre. Planning will also be required in order to absorb the associated processing and storage work for cellular therapy products for HSCT in the WCTU. In addition, we will continue to work with UCL to support enhancement of the infrastructure for translational research. The UCL site has extensive haematological research facilities and we have plans for expansion to accommodate another 20-30 staff involved in haematological cancer related research. More detailed analysis of the capacity requirement will be carried out in conjunction with the Royal Free team as part of the implementation process to finalise the proposed moves.

Interim Support for Haematology at RFH 9.9.

The RFH provides excellent haematology services. Achieving the transfer of services for cancer patients to UCLH described above will take some time. While this is being planned, it is important that the strengths of the haematology service at the RFH are maintained, and that specialist staff (medical, nursing, pharmacy and other specialist staff supporting haematology) are supported to continue to develop their services and to be involved in planning for the larger service at UCLH. We therefore propose a separate work stream to agree interim operational policies between UCLH and RFH to support haematology services at the RFH during this period. This may include bringing clinical policies and protocols for management of haematological malignancies closer together across UCLH and the RFH, and introducing staff rotations and joint working where this is appropriate to retain their high quality. We propose that Dr Ronjon Chakraverty is the identified clinical lead to chair this important work.

Working with London Cancer and Other NHS Trusts 9.10. To achieve the maximum benefits for the population of North and East London from these changes, we will work closely with other providers of clinical haematology services. The London Cancer Pathway board for haematology will be undertaking a Phase 2 of this process to define more closely the best pathways for patients and the best disposition of level 1, 2a, and 2b services (BCSH definitions) across North and East London. We will cooperate fully with this important work and Dr Kirsty Thomson, clinical lead for Haematology, will join the London Cancer technical group for this discussion. We believe that patients gain the best benefit when the services of local hospitals work closely with the specialist centre.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Organisational Capacity/Impact of Change

9.11. We recognise the potential for major improvements in outcomes for patients from improvements in the speed, accuracy, and comprehensiveness of the diagnosis of haematological malignancies. We support the view that this should be achieved by the introduction of the single integrated haematological malignancy diagnostic service (SIHMDS) across the whole of London Cancer. We will work with the other Trusts across London Cancer to deliver this. 9.12. Our proposals will mean that UCLH and Barts Health will be the providers of bone marrow transplant and highly specialised services for patients with haematological malignancies. We will continue to work with Barts Health to align our work on the development of specialist services, maximising the research opportunities, and ensuring that a consistently high standard of service is offered to all patients from North and East London requiring bone marrow transplants or highly specialised treatments for haematological malignancies.

We are already working closely with Barts Health on

arrangements for clinical trials. We believe that increasing participation in clinical trials has real benefits for the wider population, both directly because entry into clinical trials provides access to the “gold standard” of treatment, and indirectly, because commitment to clinical trials activity ensure the early introduction of improved treatments and drives up quality for everyone.

Other Discussions about Wider Haematology Services 9.13. These plans for services for patients with haematological cancer will impact on wider haematology services. We believe that the RFH will and should retain an effective haematology Department after the transfer of HSCT, acute leukaemia, and allied services to UCLH. There are many clinical and academic services at RFH which do and should continue to work closely with haematology. The details of how this should best be achieved will require further discussion between clinical and managerial staff at both Royal Free and UCLH. 9.14. A very successful informal network already links the clinical services for patients with sickle cell disease and thalassaemia primarily provided at UCLH and the Whittington, but encompassing the provision of services at the RFH, Barnet Hospital, and Luton and Dunstable Hospitals.Within UCLH, this patient group are treated in the UCH Macmillan Cancer Centre and enjoy the benefits of the environment, facilities, specialist clinical services, and supportive care provided to cancer patients at UCLH. We would expect discussion of the future configuration of haematology services to consider how this network can be strengthened and developed between the Trusts.

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Organisational Capacity/Impact of Change

Impact of Change 9.15. The argument for the expansion of services for haematological cancer at UCLH is compelling and would provide impact within and outside of London Cancer. 9.16. We have considered how we will manage the changes to the Haematological Cancer Services that result from the proposals set out in this document. We have addressed two different scenarios according to whether or not our application to host the local and specialist services is successful.

Impact if Successful 9.17. If successful we would Consolidate and sustain the position of UCLH/UCL as a centre of excellence for the treatment of haematological cancers, improving outcomes and experience for patients Optimise access to clinical trials, resulting from cutting edge translational work within the Cancer Institute and other partner organisations Further strengthen collaboration and enhance output within the academic Department of Haematology.

Impact if Unsuccessful 9.18. UCLH is committed to the development of specialist cancer services and confident in our ability to deliver both the short and the long term aspirations for Haematological Cancer Services laid out by London Cancer. If we are unsuccessful this would weaken the comprehensive approach UCLH is adopting to cancer care and so would compromise our ability to match the best cancer providers in the world. 9.19. If UCLH is not supported to deliver our comprehensive vision for cancer services, there will also be an impact on our ability to withstand financially the transfer of cardiac services to Barts Health, as has been proposed to achieve the UCL Partners vision for both cancer and cardiac services. Any detrimental impact on the financial health of UCLH as a whole would impact on the quality of care we are able to provide overall for our patients.

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Organisational Capacity/Impact of Change

Implementation Plan

LONDON CANCER

J

J

2013 A S O

N

D

J

F

M

Pathw ay Board review London Cancer Board review UCLP Executive Group meeting Public consultation

UCLH, RFH and PARTNER TRUSTS

Phase 2 Bid submission Detailed case mix / activity analysis Interim Operational Policy to support Royal Free Hospital UCLH implementation plans at UCLH Pathw ay protocals and SLA's finalised Clinical governance agreed Start of new pathw ay

72

A

M

2014 J J

A

S

O

N

D

J

F

M

2015 A M

J

J

A

Improving Services for Haematological Cancer: UCLH Application to London Cancer

Organisational Capacity/Impact of Change

Investment Requirements 9.20.

UCLH has a strong track record of investing in service developments. This document details some of the areas where investment is likely to be required; further investment required to deliver the proposals for Haematological Cancer Services will be identified during the implementation planning phase that would follow the outcomes of the public consultation exercise.

Trust Board Commitment to Implementation 9.21. The Board of Directors of UCLH NHS Foundation Trust has recently reaffirmed their commitment to supporting the development of world class cancer services at UCLH working within London Cancer. This strategic commitment underlines our operational commitment to make available the skilled medical, nursing, and other staff, and the beds, daycare capacity, outpatient space, and other resources needed to deliver the Haematological Cancer Service as outlined in the specification prepared by London Cancer. .

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Improving Services for Haematological Cancer: UCLH Application to London Cancer

Conclusion

10. Conclusion: A High Quality Service for Patients and Carers 10.1. We are delighted to have the opportunity to submit this tender to support London Cancer in the delivery of high quality, outcome focused Haematological Cancer Services. We believe the service presented in this bid demonstrates that UCLH is particularly well placed to deliver both the current and future developments.

Capacity and Commitment 10.2. ULCH is a successful and financially strong Trust with a proven Board level commitment to Cancer Services. We have a history of implementing significant pathway changes to the benefit of patients and have an estates strategy which supports the development of specialist cancer work at the UCLH site. We have a proven experience of joint working and can bring to bear the resources and depth of expertise necessary to cope with the demands on the services, both now and in the future.

Acknowledgements 10.3. In creating this application we would like to express our thanks for contributions from UCL academics, UCLH clinicians, managers and allied health professionals, representatives from our partner organisations and patient representatives, who have helped to shape our proposal. We trust that our proposals meet with the requirements of London Cancer.

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Appendices

Appendix A: Outline of Proposed Level 2b (+AML) Unit Part of pathway Early detection of patients with haematological malignancy –

High-level summary of specification Haematologists, familiar with the management of haematological malignancies on-site during working hours and available out of hours so that these patients can be picked up early.

Proposal There is an attending system in place which means that at any time there will be both a consultant haematologist specialising in the management of haematological malignancies, and an HSCT consultant available to input into the care of both newly diagnosed patients as well as existing inpatients. They are on site during working hours and available for input out of hours 24/7. Within the Trust, there is a junior doctor (ST1/2) dedicated to haematology on site at all times, who will work closely with A&E and the Acute Medical Unit in the case of new presentations, escalating to middle grade and senior specialist haematology staff to ensure appropriate management. There are haematology specialist registrars (ST3+) on site during working hours Mon-Fri and during the daytime Sat/Sun. At all other times there are 1-2 specialist registrars (ST3+) on call.

Robust partnership working arrangements are in place with referring Trusts to ensure prompt and accurate risk stratification and referral of patients appropriate for HSCT to the transplant team, or to

Robust partnership working is in place, consolidated with a series of consultant haematologist joint appointments and joint working relationships, including MDT arrangements (see Chapter 6). Consultant to consultant discussion is a standard part of the pathway in the early stages of a patient’s clinical course.

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Developments necessary

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Part of pathway

High-level summary of specification

Appendices

Proposal

Developments necessary

make the transplant team aware of the patient early in their clinical course. Radiology

Pathology

Availability

On-site 24 hours

There is 24 hour access to radiology on-site

Reporting

Consistent reporting format.

The reporting format is standard for each imaging modality employed.

Pathology services available seven days a week.

All departments are fully available during working hours, and clinical biochemistry, haematology and blood transfusion are available 24/7 via an on call service.

Histopathology meets IOG standards.

Diagnosis

Diagnosis should be timely and accurate. This will be achieved by conforming to Peer Review requirements around SIHMDS and is provided by an expert haematohistopathology.

Yes – meets full standards with access to all investigational modalities (see Diagnosis below re SIHMDS) The whole MDT work together to ensure timely and accurate diagnosis and initiation of appropriate treatment. Two dedicated, experienced, and specialist consultant haemato-histopathologists work as part of the UCLH MDT (2 WTE), supported by a third UCLH histopathologist and a clinical fellow. This team also supports services at the Royal Free Hospital. At present the SIHMDS is not in place, however UCLH are committed to working with Trusts across London Cancer to implement this.

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We recognise the potential for major improvements in outcomes for patients from further improvements in the speed, accuracy, and comprehensiveness of the diagnosis of haematological cancers. We support the view that this should be achieved by the introduction of 2 integrated haematology malignant diagnostic services (SIHMDS) across the London Cancer each with a catchment area of 2 million. We will work with the other Trusts across London Cancer and pathology services to deliver this.

Improving Services for Haematological Cancer Services: UCLH Application to London Cancer

Part of pathway

High-level summary of specification

MDT

Meets IOG and DH standards.

Appendices

Proposal We have a fully compliant joint MDT for Leukaemia and Lymphoma. Recent self-assessment against Peer Review measures for the Lymphoma and Leukaemia MDT resulted in 82.4% compliance.

Staffing

Medical

24 hour cover by attending consultant haematologist. On-site designated junior trainee or sub-consultant non-career grade during weekdays.

Nursing

On-site 24 hour cover with specialist haemato/oncology trained nurses; ability to immediately increase ratio to 1:2 patients as required. 24 hour cover by attending consultant haematologist.

There is a 24 hour haematology consultant cover, with an attending rota giving 2 month long continuity of care. There are haematology specialist registrars (ST3+) and SHOs available on site during working hours. There is a dedicated junior and middle grade doctor rota both of which provide 24/7 cover, with a Haematology SHO (ST1/2) onsite at all times. The haematology wards are staffed 24 hours a day exclusively by registered nurses, all of whom are specifically haematology or HSCT trained. On both wards, the average nurse: patient ratio is 1:3, with a range of 1:1 to 1:5 depending on case mix and acuity – the ratio can be flexible as required.

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Developments necessary

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Part of pathway Outpatient care

High-level summary of specification Haemato-oncology day unit providing facilities for isolation, long duration intravenous infusions, blood component transfusions.

Appendices

Proposal

Developments necessary th

Day care is on the 4 floor of the Macmillan Cancer Centre. There are 2 bays with treatment chairs, a 4 bedded bay, 4 single rooms for procedures and isolation where required and 1 room for pentamidine. The day unit is open 0830- 1900, allowing for long duration infusions. There is an overnight bed available on the inpatient unit to accommodate any overrunning of infusions, e.g. if a patient has a reaction during an infusion requiring the treatment to be administered more slowly. In addition there is an Apheresis unit with 6 beds and 2 side rooms served by 8 apheresis machines and a dedicated team of apheresis nurses, who provide 24/7 care.

Inpatient beds

Isolation facilities (en suite) in ward designated for haematology patients; ability to administer overnight chemotherapy infusions.

UCLH have 34 Adult single en suite inpatient beds. 9 of these rooms have HEPA filtration. In addition there is a 12 bedded Young Adult Unit for haematology and oncology patients aged 20-24, which includes 4 en suite side rooms for patients who require isolation. In addition, haematology patients who develop infections are moved to the infection th ward on the 8 floor of the Tower. Haematology nurses maintain close links with patients whilst on this ward working closely with infection ward nurses. Chemotherapy infusions are administered overnight routinely in the inpatient unit.

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Part of pathway

High-level summary of specification

Appendices

Proposal

Pharmacist

Dedicated haemato-oncology pharmacist.

UCLH has 3 specialist haematology pharmacists, 2 rotational cancer services pharmacists and a medicines management technician.

High Dependency Unit

On-site

UCLH have an on-site HDU as part of a 35 bed critical care unit.

Intensive Therapy Unit access

On-site

UCLH have an on-site ITU as part of a 35 bed critical care unit.

Treatment

Holistic needs assessment

All patients are offered holistic needs assessment at the time of diagnosis.

We are not yet meeting this objective but are participating in the Macmillan holistic needs assessment project. The HNA has already been piloted in some haematology clinics.

Workload

If patients with AML are to be treated intensively a minimum of 10 new patients need to be treated intensively per year on average. This is to ensure that staff are familiar with the administration and complications of such protocols.

In 2012/13, 34 patients with AML were treated intensively at UCLH.

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Developments necessary

A full implementation plan is under development for the comprehensive use of holistic needs assessment in haematological cancers as part of the UCLH HNA programme. It is expected that HNA will be offered at diagnosis and at other key points of the pathway.

Improving Services for Haematological Cancer Services: UCLH Application to London Cancer

Part of pathway

High-level summary of specification Joint working

Chemotherapy

Radiotherapy

Appendices

Proposal

To ensure expertise is brought into the management of patients whilst allowing local and personalized care, level 2b units, should, as a minimum, either have joint appointments with a level 3 unit and/or a combined MDT with the level 3 unit. This is particularly important when transplantation is an option in the patient’s pathway.

As an integrated unit, we are able to offer directly integrated access to Level 3 care.

Emergency access to chemotherapy

Access to out-of-hours cytotoxic pharmacy advice line.

On call chemotherapy pharmacists are available 24/7 for advice and out of hours chemotherapy can be produced at any time, 365 days of the year.

Radiotherapy facilities

Units have access to radiotherapy facilities: not necessarily on site.

There is a state-of-the-art radiotherapy department at UCLH equipped with the latest technology including 5 Varian Linacs.

Access to clinical oncology expertise

Designated consultant clinical oncologist available for consultation and input.

There are named clinical oncologists with expertise in haematological malignancy who have responsibility for provision of services to patients requiring radiotherapy in relation to disease sites, and for Total Body Irradiation (TBI) for adult HSCT patients. Separate paediatric clinical oncologists provide the same services for adolescents.

Ensuring continuity of service

Cross-cover arrangements in place with at least one other consultant clinical oncologist able to continue service provision for urgent cases.

There are appropriate cover arrangements in place for both adult and paediatric consultant clinical oncologists.

Access to emergency chemotherapy production out-ofhours.

We work jointly with other units to ensure access to Level 2b and 3 care for their patients.

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Part of pathway

High-level summary of specification Referral

Patient-centred care: fertility, psychological, specialist and general palliative care, social support, complementary therapy, spiritual, carer support and bereavement

Appendices

Proposal

All cases are discussed at MDT. Timely referral pathway agreed for patients requiring radiotherapy after systemic therapy so as to minimise delay in starting radiotherapy following completion of chemotherapy.

All potential patients for radiotherapy are discussed at MDT. Many patients have radiotherapy planned from the outset and referral to the clinical oncologist is triggered routinely by agreed pathways as the chemotherapy cycle draws to an end. Patients in whom the end of treatment scan indicates radiotherapy would be of benefit are discussed at the MDT and referred on immediately afterwards

Meets IOG standards.

We are able to offer all of the elements of supportive, patient centred care as outlined in the IOG.Fertility specialists for both genders are available on site, and can be readily accessed to optimise fertility preservation pre-treatment and/or assist with fertility issues after treatment has completed. Within the Macmillan Support and Information Service, there are 2 adult haematology counsellors, a clinical psychologist, complementary therapists (massage, reiki, aromatherapy, reflexology), patient and carer support including bereavement support. The hospital has a chaplaincy service. Comprehensive information is available from the Macmillan Support and Information team, in support of the site specific Clinical Nurse Specialists, including specialist advice about welfare and benefits. There is a full palliative care team with appropriate community links, and symptom control and pain management is also provided by this team. The TYA service has

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Developments necessary

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Part of pathway

High-level summary of specification

Appendices

Proposal

Developments necessary

the full range of specialists available, from adolescent-trained consultant and nursing staff, to social workers, psychologists/counsellors and other critical support staff, including access to adolescent psychiatry services and strong links with the Teenage Cancer Trust and CLIC Sargent. Further details are outlined in Chapter 3. Acute oncology

Full acute oncology service that meets Peer Review standards.

Post-treatment

All patients given a clear end of treatment plan. Access to appropriate follow up facilities for those requiring hospital based follow up for late effects. GPs manage patients who have been discharged at end of treatment, and have clear guidance regarding reasons for referral back to secondary care and routes available with named contacts and up to date details.

Agreed pathways in place including consultant review of all emergency admissions within 24 hours All patients are reviewed in clinic at the end of treatment and provided with a written record of that consultation.

Full compliance with Peer Review standards and development of outcome measures with London Cancer Implement standardised end of treatment plan for all patients.

In addition to the follow up care provided by each MDT, UCLH also has a late effects service for adult patients which it runs in conjunction with GOSH. This ensures appropriate multidisciplinary care for those with more complex long term follow up requirements as a result of their acute treatment. All clinical documents and communication clearly state contact details for the department for GPs to discuss concerns or refer back to the team, together with the late effects of treatment the GP should be aware of, in the rare cases where a patient is discharged

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UCLH are appointing a project manager to develop models of follow up including supported self management. Within their brief they will look at how GPs are informed at discharge. Haematology will be one of the tumour types included in this project.

Improving Services for Haematological Cancer Services: UCLH Application to London Cancer

Part of pathway

High-level summary of specification

Palliative care

Clinical trials, research and innovation

Patient travel

Appendices

Proposal

Clear referral pathways for patients with palliative and specialist palliative care needs.

There are currently clear pathways for patients with palliative and specialist palliative care needs. There is also a daily presence on the ward and a weekly consultant ward round.

Clinical trials

Patients offered trial entry when a suitable trial is available.

It is policy that every patient discussed at the MDT is considered for any suitable clinical trials. Full details of all trials activity is provided in appendix D.

Research nurse support

On-site

The Haematology trials team has 7.5 research nurses and 5.0 other staff. It is based onsite and is integrated closely with the workings of the clinical team.

Audit

Carries out prospective audit of service and publishes transparent outcomes data.

There is a rolling programme of audit within the Haematology department, which includes clinical outcomes and patient experience audit. Outcomes have been published in peer review journals for over 3 decades. When more outcome data is available through the NCIn this will also be made public.

Informs patients of support available for travel to specialist centres and radiotherapy units. Robust patient travel plans in place, reflecting provision for safe and timely transfer between sites.

UCLH will provide clear information about travel and transport to staff in referring hospitals with details about travel options available. Immuno-compromised patients will continue to be eligible for the provision of NHS funded transport, provided in personal use vehicles, if indicated. There are further specific transport entitlements for transplant patients (see chapter 7)

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Appendices

Appendix B: Outline of Proposed Level 3 HSCT unit Part of pathway

High-level summary of specification

Early detection of patients with haematological malignancy

Proposal

Haematologists, familiar with the management of haematological malignancies on-site during working hours and available out of hours so that these patients can be picked up early.

There are 3 consultants specialising in adult HSCT, with additional input from 4 more consultants with disease-specific interests. There are also 2 consultants specialising in adolescent HSCT. The HSCT consultants provide an attending rota to ensure 24/7 input is available.

Radiology

Availability

On-site 24 hours

There is 24 hour access to radiology on-site

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Reporting

Pathology

Appendices

Consistent reporting format

The reporting format is standard for each imaging modality employed.

Pathology services available seven days a week.

All departments are fully available during working hours, and clinical biochemistry, haematology and blood transfusion are available 24/7 via an on call service.

Histopathology meets IOG standards

Yes – meets full standards with access to all investigational modalities (see Diagnosis below re SIHMDS) MDT

Meets IOG and DH standards.

We have a fully compliant joint MDT for Leukaemia and Lymphoma. Recent self-assessment against Peer Review measures for the Lymphoma and Leukaemia MDT resulted in 82.4% compliance.

Staffing

Medical

24 hour cover by attending consultant Haematologist. 24-hour specialist middle grade cover (not necessarily onsite). Onsite designated Haematology junior trainees during weekdays.

There is a 24 hour haematology consultant cover, with an attending rota giving 2 month long continuity of care. There are haematology specialist registrars (ST3+) and SHOs available on site during working hours. There is a dedicated junior and middle grade doctor rota both of which provide 24/7 cover, with a Haematology SHO (ST1/2) onsite at all times.

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Nursing

Appendices

The haematology wards are staffed 24 hours a day exclusively by registered nurses, all of whom are specifically haematology or HSCT trained. On both wards, the average nurse: patient ratio is 1:3, with a range of 1:1 to 1:5 depending on case mix and acuity – the ratio can be flexible as required.

On-site 24 hour cover with specialist haemato/oncology Trained nurses; ability to immediately increase ratio to 1:2 patients as required.

Outpatient care

Haemato-oncology day unit -providing facilities for isolation, long duration intravenous infusions, blood component transfusions.

th

Day care is on the 4 floor of the Macmillan Cancer Centre. There are 2 bays with treatment chairs, a 4 bedded bay, 4 single rooms for procedures and isolation where required and 1 room for pentamidine. The day unit is open 0830- 1900, allowing for long duration infusions. There is an overnight bed available on the inpatient unit to accommodate any overrunning of infusions, e.g. if a patient has a reaction during an infusion requiring the treatment to be administered more slowly. In addition there is an Apheresis unit with 6 beds and 2 side rooms served by 8 apheresis machines and a dedicated team of apheresis nurses, who provide 24/7 care.

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Inpatient beds

Appendices

Isolation facilities (en suite) in ward designated for haematology patients.

UCLH have 34 Adult single en suite inpatient beds. 9 of these rooms have HEPA filtration. In addition there is a 12 bedded Young Adult Unit for haematology and oncology patients aged 20-24, which includes 4 en suite side rooms for patients who require isolation. In addition, haematology patients who develop infections are moved to the th infection ward on the 8 floor of the Tower. Haematology nurses maintain close links with patients whilst on this ward working closely with infection ward nurses.

Pharmacist

Dedicated haemato-oncology pharmacist

3 specialist haematology pharmacists, 2 rotational cancer services pharmacists and a medicines management technician

High Dependency Unit

On-site

UCLH have an on-site HDU as part of a 35 bed critical care unit.

Intensive Therapy Unit access

On-site

UCLH have an on-site ITU as part of a 35 bed critical care unit.

Treatment

Undertakes at least 100 HSCT cases per year.

UCLH meets this specification.

Workload

In 2012/13 UCLH undertook 140 adult HSCT cases and treated 34 Acute leukaemia patients intensively.

Same caveat applies re intensively treated AML patients as for level 2b units.

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Chemotherapy

Joint working

To ensure expertise is brought into the management of patients whilst allowing local and personalized care, level 3 units, should, as a minimum, either have joint appointments with level 1, 2a or 2b units and/or a combined MDT with these units level 3 unit. This is particularly important when transplantation is an option in the patient’s pathway.

UCLH has joint appointments with Level 1, 2a and 2b units. Full details are in Chapter 6 of the document.

Emergency

Access to out-of-hours cytotoxic pharmacy advice line.

On call chemotherapy pharmacists are available 24/7 for advice and out of hours chemotherapy can be produced at any time, 365 days of the year.

access

Radiotherapy

Appendices

to

chemotherapy

Access to emergency chemotherapy production out-of-hours.

Radiotherapy

Radiotherapy service required on site.

There is a state-of-the-art radiotherapy department at UCLH equipped with the latest technology including 5 Varian Linacs.

One nominated consultant clinical oncologist with site specialisation in haematological malignancy and TBI (Total Body Irradiation); also responsible for the TBI service, available for consultation and input.

There is a named clinical oncologist with expertise in haematological malignancy who has responsibility for provision of services for Total Body Irradiation (TBI) for adult patients and a separate paediatric clinical oncologist with responsibility for adolescents.

At least two consultant clinical oncologists available for service provision continuity with both also able to consent, plan and prescribe TBI (to provide cover for absence).

There are appropriate cover arrangements in place for both of the consultant clinical oncologists (supporting adult and paediatric work), with additional clinical oncologists available to provide cover for TBI services

facilities Access

to

clinical oncology expertise

Ensuring continuity service

of

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Referral

Appendices

All potential patients for radiotherapy are discussed at MDT. There are written policies for referral, planning and delivery of TBI

All cases are discussed at MDT. Timely referral pathway agreed for patients requiring radiotherapy after systemic therapy so as to minimise delay in starting radiotherapy following completion of chemotherapy.

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Patient-centred psychological,

care:

fertility,

specialist

Appendices

Meets IOG standards.

We are able to offer all of the elements of supportive, patient centred care as outlined in the IOG.

and

general palliative care, social support,

Fertility specialists for both genders are available on site, and can be readily accessed to optimise fertility preservation pre-treatment and/or assist with fertility issues after treatment has completed

complementary

therapy, spiritual, carer support and bereavement

Within the Macmillan Support and Information Service, there are 2 adult haematology counsellors, a clinical psychologist, complementary therapists (massage, reiki, aromatherapy, reflexology), patient and carer support including bereavement support. The hospital has a chaplaincy service. Comprehensive information is available from the Macmillan Support and Information team, in support of the site specific Clinical Nurse Specialists, including specialist advice about welfare and benefits. There is a full palliative care team with appropriate community links, and symptom control and pain management is also provided by this team. The TYA service has the full range of specialists available, from adolescenttrained consultant and nursing staff, to social workers, psychologists/counsellors and other critical support staff, including access to adolescent psychiatry services and strong links with the Teenage Cancer Trust and CLIC Sargent. Further details are outlined in Chapter 3.

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Acute oncology

Full acute oncology service that meets Peer Review standards.

Post-treatment

All patients given a clear end of treatment plan.

Appendices

Access to appropriate follow up facilities for those requiring hospital based follow up for late effects.

Palliative care

Clinical research

trials,

Agreed pathways in place including consultant review of all emergency admissions within 24 hours

Full compliance with Peer Review standards and development of outcome measures with London Cancer

All patients are reviewed in clinic at the end of treatment and provided with a written record of that consultation.

Implement standardised end of treatment plan for all patients.

In addition to the follow up care provided by each MDT, UCLH also has a late effects service for adult patients which it runs in conjunction with GOSH. This ensures appropriate multidisciplinary care for those with more complex long term follow up requirements as a result of their acute treatment.

Clear referral pathways for patients with palliative and specialist palliative care needs.

There are currently clear pathways for patients with palliative and specialist palliative care needs. There is a daily presence on the ward and a weekly consultant ward round.

Clinical trials

Patients offered trial entry when a suitable trial is available.

It is policy that every patient discussed at the MDT is considered for any suitable clinical trials. Full details of all trials activity is provided in appendix D.

Research

On-site

The Haematology trials team has 7.5 WTE research nurses and 5.0 WTE other staff. It is based onsite and is integrated closely with the workings of the clinical team.

and

innovation

nurse support

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Audit

Patient travel

Appendices

Carries out prospective audit of service and publishes transparent outcomes data.

There is a rolling programme of audit within the Haematology department, which includes clinical outcomes and patient experience audit. Outcomes are regularly published in peer review journals, and data is returned to the national and international registries in order to demonstrate transparent outcomes. HSCT outcome data is also returned to the commissioners via the National Dashboard Pilot (see chapter 8)

Informs patients of support available for travel to specialist centres and radiotherapy units

UCLH will provide clear information about travel and transport to staff in referring hospitals with details about travel options available. Immuno-compromised patients will continue to be eligible for the provision of NHS funded transport, according to the specific transport entitlements for HSCT (see chapter 7)

Robust patient travel plans in place, reflecting provision for safe and timely transfer between sites.

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Appendix C: Clinical Trials Recruitment in Haematology Research and Clinical Trials The past year has seen an expansion of the haematology research portfolio, particularly in CLL. The increase in the number of local CI's on academic and commercial trials confirms the status of this department as a major centre for clinical research. Our most significant achievement this year has been the appointment of Dr Rakesh Popat to lead in developing our portfolio of early phase studies across haematology. Since his appointment, five new Phase 1/ 2 trials have opened, with several more in the pipeline. To ensure a transparent and balanced consideration for academic leadership, scientific competitiveness and patient need, we are currently piloting a Trial Prioritisation Tool to score new trials. We also have a new Trials Core Steering Group that will meet quarterly to review the trials adoption and set-up process, disease-specific algorithms, incidents, staffing and funding. The haematology trials unit has continued to expand. Leukaemia has seen the largest increase in activity, with recruitment being up by 15 per cent compared to last year. There will soon be an addition of two further phase II studies to this portfolio. Lymphoma remains the second highest recruiter in the UK to the ORCHARD study. Myeloma remains the busiest area with 4 research staff. The transplant portfolio has also expanded and recruitment has commenced into the first gene therapy study. A second gene therapy study has also recently opened and the first patient is in screening. Tumour

Study Acronym / Short Title

Phase

Academic/Commercial

ALL

UKALL 60

2

Academic

AML / ALL

Hedgehog

2

Commercial

Leukaemia

Spirit 3

3

Academic

Lymphoma

GA101

3

Commercial

CLL

Ibrutinib CLL

2

Commercial

Predicted Annual Recruitment

Potential trials

93

2 in total

Screen Failures 2012-13

Recruitment 2012-13

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Phase

Appendices

Tumour

Study Acronym / Short Title

Academic/Commercial

Predicted Annual Recruitment

CLL

Gilead 115

Commercial

2 total

Lymphoma

Mantle cell RAY

3

Commercial

Lymphoma

INCA

2

Academic

Lymphoma

Chemo-T

2

Academic

Lymphoma

R2W

2

Academic

BMT

FIGARO

Screen Failures 2012-13

Recruitment 2012-13

Open Trials CLL

LenD

2

Academic

3 to 4

0

5

CLL

Cosmic

2

Academic

5

1

0

CLL

CLL210

2

Academic

4

1

0

AML

AML17

3

Academic

16

0

13

AML

AML LI-1

Phase 2/3

Academic

4

2

4

AML

AML18 Pilot

1B/2

Academic

4

1

6

ALL

UKALL14

Phase 1/2

Academic

5

0

6

MM

Bortezomib Consolidation

2

Academic

total 45

0

11

MM

Eloquent 1

3

Commercial

4

2

0

MM

MUK 5

2

Academic

8 to 10

0

3

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Appendices

Tumour

Study Acronym / Short Title

Phase

Academic/Commercial

Predicted Annual Recruitment

Screen Failures 2012-13

Recruitment 2012-13

MM

MUK3

Phase 1/2a

Academic

6

0

0

MM

Anti-Baff

Phase 2/3

Commercial

5

1

3

MM

Siltuximab

2

Commercial

4

MM

PADIMAC

2

Academic

8

1

15

MM

NCRN283 (MLN9708)

Phase 1/2

3

0

0

Transplant

CMV-ACE/ASPECT

2

Academic

3 per year

3

4

Transplant

CMV IMPACT

3

Academic

3

1

5

Transplant

IRES (MAC & RIC sub study)

Academic

unknown

0

0

Transplant

WT1 Gene therapy

Phase 1/2

Academic

2

5

1

Transplant

CMV gene therapy

1

Academic

4

1

0

Transplant

LENARIC

2

Academic

2 per year

2

0

Transplant

MAC UCBT

2

Academic

2

0

0

Transplant

PAIRED

2

Academic

3 per year

1

4

Transplant

Pro T4

2

Academic

2 to 3

0

1

Transplant

RIC UCBT

2

Academic

2

1

0

Transplant

MCL mini allo

2

Academic

2 to 3

1

0

Lymphoma

R Codox M

2

Academic

5

95

0

5

Improving Services for Haematological Cancer Services: UCLH Application to London Cancer

Appendices

Tumour

Study Acronym / Short Title

Phase

Academic/Commercial

Predicted Annual Recruitment

Screen Failures 2012-13

Recruitment 2012-13

Lymphoma

REMoDL-B

3

Academic

3

2

0

Lymphoma

OrchaRd

3

Commercial

4

4

2

Lymphoma

Pacifico

3

Academic

5

Lymphoma

NHSLG

3

Academic

40

1

20

Lymphoma

MabCute

3b

Commercial

3

5

4

Lymphoma

IELSG

2

Academic

3 to 4

1

1

Lymphoma

EBV NKT

Academic

5

Lymphoma

ITCL

2

Academic

1

MM

MYELOMA XI

3

Academic

6

MM

Eloquent 2

3

Commercial

6

1

MM

Focus

3

Commercial

6

11

MM

KW2478

Phase 1/2

Commercial

total 24

0

3

MM

MM015

3

Commercial

8

n/a

n/a

MM

Panobinostat

3

Commercial

4 to 5

n/a

n/a

AML

AML16

3

Academic

12

3

1

0

1 1

0

Closed - active pts

96

0

0

Improving Services for Haematological Cancer Services: UCLH Application to London Cancer

Appendices

CML

SPIRIT 2

3

Academic

Unknown

0

2

Lymphoma

RATHL

3

Academic

5 to 10

Lymphoma

RATHL Ovarian sub-study

3

Academic

Lymphoma

R-CHOP 14 PET substudy

3

Academic

total 10

MM

MYELOMA X

3

Academic

6

MM

MUK 1

2

Academic

6 to 8

MM

ICORG PAD

2

Academic

4 to 5

Lymphoma

18-30

2

Academic

5

0

Lymphoma

FORT

3

Academic

unknown

0

Lymphoma

RAPID

3

Academic

5

0

Lymphoma

RGCVP

2

Academic

unknown

Lymphoma

Stanford V

3

Academic

5

Lymphoma

Watch and Wait

3

Academic

total 10

Lymphoma

Amgen KGF

3

Commercial

unknown

CLL

CLL 207

2

Academic

5

CLL

ADMIRE - CLL6

2

Academic

3 to 5

8 1 3

Closed-follow-up

Closed -archived - or to be archived

97

1

2

0 0

0

Improving Services for Haematological Cancer Services: UCLH Application to London Cancer

Appendices

MM

Velcade - Doxil

3

Commercial

unknown

MM

Novartis BHQ

2

Commercial

3 to 4

0

MM

Consolidated HDT

2

Academic

7

0

Transplant

GCSF donors

4

Academic

total 35

8

Transplant

REACH

2

Academic

total 9

0

CRF Study

Going through R & D

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Appendix D: Donor and Patient Surveys

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Appendix E: Letters of Support

UCL CANCER INSTITUTE PROFESSOR CHRIS BOSHOFF FRCP PhD FMedSci

21st July 2013 To: The London Cancer Panel for Haematopoietic Stem Cell Transplantation and Acute Leukaemia The bone marrow transplant and acute leukaemia research programme associated with UCL, UCLH and the Royal Free Hospital (RFH) is internationally recognised. UCL with our partner hospital, UCLH, is committed to develop the haematopoietic transplantation and acute leukaemia programme further, and to maintain its reputation as a national Centre of Excellence. The outcome of patients with acute leukaemia is dependent on a close relationship between world-class research, including basic, translational and clinical, and a multidisciplinary team of clinicians and allied professionals. The close relationship between the UCLH and RFH services, and the research activities in the UCL Cancer Institute has been essential for the success of this programme. The clinical strategy between UCLH and the RFH is similar and the two transplant programmes share clinical and trial protocols as reflected by their joint publications. Most of the clinicians involved in the leukaemia and transplant programmes at UCLH and the RFH have joint academic appointments at UCL, or are fully employed by UCL. The UCL/UCLH/RFH leukaemia team has published more papers in the top haematological Journal Blood, than any other centre in the U.K. Their research programme has transformed the care of individuals with acute leukaemia. This is exemplified by the fact that two of the impact statements (‘impact beyond research’) for the UCL REF2014 return will be based on the acute leukemia and the bone marrow transplant programmes between UCL and our two major hospitals, UCLH and the RFH. The research strengths of UCL in acute leukaemia include the development of immunotherapeutic protocols; early and late phase clinical trials; stratification based on genetic profiles; and basic research related to stem cell biology. With the recruitment of Tariq 107

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Enver our stem cell biology programme is now internationally at the forefront. The haematological service at UCLH was the first in the UK to introduce routine molecular profiling to all patients with acute leukaemia. The development of whole exome sequencing for this service should keep us internationally at the forefront. Our future strategy includes plans to move the RFH service and research activities to the UCLH/Bloomsbury campus to further align clinical service and research approaches. Haematopoietic Stem Cell Transplantation and Acute Leukaemia is one of the major programmes of our CRUK UCL Centre, and future CRUK funding from this Centre will be used to further strengthen essential leukaemia core resources; biobanking; clinician scientist recruitment; increase capability for Phase I trials; molecular profiling; pump-priming collaborations between fundamental and clinical researchers; and fostering interactions with stem cell and leukaemia researchers at the Francis Crick Institute.

Yours sincerely

Chris

Boshoff

FRCP

PhD

FMedSci

|

Director

UCL

Cancer

Institute

Paul O’Gorman Building | University College London | 72 Huntley Street | London | U.K.

|

WC1E

Tel: +44 20 7679 6850 (internal 46850) | http://www.ucl.ac.uk/cancer

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Department of Haematology Dr Gavin Campbell Consultant Haematologist Dr Sudhakaran Makkuni Consultant Haematologist

Dr Mike Hamblin Consultant Haematologist Joanne Tonkin Nurse Consultant

Appendices

Dr Marion Wood Consultant Haematologist

Colchester General Hospital Haematology Department Turner Road Colchester Essex CO4 5JL Tel: 01206 742357 Fax: 01206 746581

Date: 18/07/2013 Ref: GNC/HV/UCLH Testimonial

CONFIDENTIAL Dr Kirsty Thomson Consultant Haematolgoist Department of Haematology University College Hospital 1st Floor Central 250 Euston Road LONDON NW1 2PJ Dear Kirsty

I have been asked to provide some feedback regarding UCLH’s status as a tertiary referral centre for our haematology patients, and I am more than happy to add my support to your bid to remain a transplant centre for London. I have been a consultant at Colchester General Hospital for nearly 10 years now, and we send quite a good deal of our lymphoma work your way for second opinions and for autologous transplants when indicated. We have not used your services for allogeneic transplants to any great degree that I am aware of but for the support we get for our lymphoma patients I have been extremely grateful. It is always easy to contact the individuals we are after, and we receive swift and succinct advice. Patients are reviewed as necessary at your multi-disciplinary team meetings, and your decisions relayed to us quickly and accurately. Patients who actually need to attend the hospital get a good service, and we have no complaints about the clinical management, with good correspondence being offered whilst patients are an in-patient and after discharge. I hope that is helpful, and I wish you well in your bid. Yours sincerely

Dr Gavin Campbell MB ChB FRCP FRCPath Consultant Haematologist

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th

19 July 2013 Prof David Linch/Dr Kirsty T hompson University College London Hospital 235 Euston Road London, NW1 2BU Dear David/Kirsty, I received a request to assess your service as a transplant and acute leukaemia unit in London. As you know, we have referred our South Essex patients to UCLH on a regular basis for many years. The trend has been to increase referrals - particularly for lymphoma patients. UCLH has a long tradition of treating these patients to the highest international, evidence based standards combined with the experience and expertise to tailor treatment for the individual patient's needs and circumstances. UCLH has a highly regarded specialist training programme and teaching facilities, with an active research programme. This attracts a high calibre of trainees from which we indirectly benefit and has enabled us to enrol suitable patients into clinical trials - offering opportunities to have novel therapies not otherwise available. The patient feedback we obtain about UCLH is excellent. We all acknowledge that it is a long distance for our patients to travel, and that it is difficult for family members to visit regularly. UCLH have been at the forefront in trying to mitigate this problem, providing privileged parking and family friendly accommodation. Patients often comment on the high standards of medical and nursing care and the high degree of continuity and consistency in the way they are managed. From a professional perspective, communication between doctors and specialist nurses is prompt, appropriate and there is regular use of email, telephone, and royal mail. Letters are comprehensive; transplant protocols and updates are regular, and shared care arrangements are clear. There is rapid and effective sharing of histology slides and images by IEP; and there is good MDT to MDT collaboration, with UCLH acting as our PTC for teenagers and young adults.

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Ultimately what matters most to patients is a good clinical outcome, and there is no doubt that many lives have been saved by the excellent services in U C L H . I remember well individual patients with highly advanced lymphoma at presentation or relapse, referred to and accepted by UCLH, never expecting to see them again, but unexpectedly appearing several weeks later alive and well. We send our sickest patients to UCLH and are often pleasantly surprised by the excellent outcomes. We hope that our relationship will continue to grow and develop such that we can combine the best of locally delivered services with the advantages of having a world class tertiary referral service at our door-step. Best Wishes

Dr Paul Cervi

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Letter of Support from Dr Joanne Howard, Consultant Haematologist, Basildon University Hospital Future of UCLH Transplant and AML Service I am writing with my full support that UCLH should remain a stem cell transplant and AML Centre. We use the HaemOnc service at UCLH as our tertiary referral centre from Basildon and Thurrock University Hospital. We receive a fantastic service from Professor Linch and his team. The Consultants are always extremely helpful and give very good advice. They are always happy to see patients urgently in their clinics and if in-patient transfer is required this is done speedily and without fuss. The team are easy to contact and we have many of the Consultant’s mobile telephone numbers. Whilst our patients are receiving treatment at UCLH we receive weekly updates of their progress. This is invaluable in planning their ongoing care. In summary, Professor Linch and his team provide an excellent patient-centred tertiary service for our HaemOnc patients. Withdrawal of this service would severely impair out patients’ management and we would struggle to find and alternative Trust which delivers such high quality care. I hope you include this letter in consideration of your final decision. Yours sincerely Dr Joanne Howard MRCP FRCPath Consultant Haematologist Email:

[email protected]

Letter of Support from Dr Judith Hanslip, Consultant Haematologist, East & North Herts NHS Trust Professor Linch I email to place on record the high esteem with which I regard the Clinical Haematology service provided to me in my position as consultant haematologist at E&N Herts NHS trust. Since 2002 UCH has been my first choice for referral of all acute leukaemia pats and pats with relapsed lymphoma/myeloma requiring salvage therapy/transplant. The service provided has been excellent and my pats talk of the wonderful doctors and treatment they received. I receive regular weekly email updates regarding inpatients which greatly improves communication and helps to flag up any issues which may need to be dealt with locally on discharge. This email communication does not appear to happen at other haematology departments to which my pats might be admitted. I also receive emails or phone calls regarding any urgent issues on outpatients who have been seen and this results in problems being dealt with more speedily. Recently the portfolio of clinical trials appears to have expanded and this means my pats now have access to some exciting novel therapies which would not otherwise be available to them. I consider UCH to be a centre of excellence for Clinical Haematology and it will remain my first choice for tertiary care referrals and my number one recommendation to my pats. Dr Judith Hanslip Consultant Haematologist CD for Cancer E&N Herts NHS Trust 112

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Letter of Support from Dr. Pawel Kaczmarek, Consultant Haematologist, Surrey & Sussex Healthcare NHS Trust Dear Professor Linch, I would like to take this opportunity and express our satisfaction with the service offered by the University College London Hospital to our patients. The Haematology Department at East Surrey Hospital has long had close links with UCLH which provided us with tertiary haematology advice. Over more than 10 years our Department has referred many patients with haematological malignancies, mainly lymphoma, to your Department. These were usually complicated cases or patients requiring consolidation treatment with high-dose chemotherapy. We have also referred patients for clinical trials and individuals with HIV-associated malignancies. Our patients have always been seen promptly and the whole process has been considered smooth by those involved. Liaison between both teams has always been very good and we found it easy to get in touch with a particular member of the UCLH team. The video-conferenced Multidisciplinary Team Meetings have always been very informative and have given our patients an opportunity to access specialist treatment and advice. We have also been able to discuss urgent cases outside of these meetings via telephone and e-mail conversations.

We can only praise the advice received from the clinicians as well as the service provided by other members of the team - Clinical Nurse Specialists, Transplant Coordinators, MDT Coordinators and secretaries. The feedback from our patients has always been very good, but importantly we see how our patients have benefited from the cooperation between our department and ULCH. We keep seeing these people for many years following their treatment and it is not unusual to meet a patient who had a stem cell transplant at UCLH ten years ago at our annual Macmillan Coffee Morning.

Yours sincerely

Dr. Pawel Kaczmarek, Consultant Haematologist Surrey & Sussex Healthcare NHS Trust

Letter of Support from Dr. Gleb Ivanov, Consultant Haematologist, Surrey & Sussex Healthcare NHS Trust Dear Professor Lynch,

I understand that bone marrow/stem cell transplant and acute leukaemia services in London are currently under review. Clearly I would like to give my full support of the UCLH’s bid to continue with the aforementioned services. I have established a link with the UCLH Lymphoma and Transplant Teams soon after being appointed as a Consultant Haematologist at Southend Hospital in 2008 and since then have received a sterling service from many members of the team. When I moved to Surrey and Sussex NHS Trust in 2011, I 113

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was very happy to find out that there was a historical and well established pathway for complex lymphoma patients to be discussed and referred to UCLH for autologous/allogeneic transplantation, complex treatments or new trials. Moreover, until recently Prof Anthony Goldstone used to lead quarterly outreach lymphoma clinics at East Surrey Hospital where more difficult cases were seen and discussed. At East Surrey Hospital we consider ourselves privileged to have monthly videolinked MDTs with the UCLH Lymphoma Team giving us access to high quality opinions in all areas of lymphoma diagnosis and management. It is difficult to overestimate the value of this meeting for patients’ care as well as its educational value for us as DGH Haematologists. I would like to add that the service provided by the UCLH team for our patients requiring high dose chemotherapy/autologous or allogeneic transplants has always been of a very high quality. The patients who are referred to UCLH for consideration of a stem cell transplant are normally seen within two, sometimes even one week. We receive communication regarding the patients’ management plans almost instantly by e-mail and post. The level of communication with the UCLH Team is really second to none – we even get weekly updates on our patients undergoing stem cell transplantation. Despite a lengthy journey, our patients are invariably happy with the level of care provided at the UCLH. The transfer of care process has always been seamless and the patients are always referred back to us at an appropriate time in their pathway. I would like to underline specifically the amount of assistance that we receive directly from Dr Kirit Ardeshna, who despite his tremendous workload is always accessible and very approachable for advice on most complex cases. I am very grateful for his unfailing support. I have little doubt that other Haematologists from our region who all these years have been benefiting from their link with the UCLH Transplant Unit would unanimously add their voice of support to your bid.

I sincerely hope that our most fruitful cooperation will be ongoing.

Yours sincerely,

Dr Gleb Ivanov MD PhD MRCP FRCPath Consultant Haematologist Surrey and Sussex NHS Trust

Tel.: 01737 768511, ext 6473 (Sec) Fax: 01737 231 694

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